The Market Access Strategy Lead (MASL) will be responsible for the overall Worldwide Market Access Strategy for one or more of BMS’s portfolio assets or combination of assets in the oncology space. He or she will provide input to the Development and Commercial Strategy organization on the Market Access Strategy. The MASL will partner with the Pricing Strategy Lead to optimize the value of the IO Franchise in the evolution of the Pricing Strategy for the IO portfolio. Partner with US organization, advocacy and policy teams and markets.

This position will work with the Development, Commercial, HEOR, and Pricing Organizations as well as all BMS Market Access and Pricing functions around the globe to drive the development of the Market Access strategy for one or more of BMS’s portfolio assets or combination of assets in the oncology space. The position is cross functional in nature and is part of a highly matrixed organization, working on a wide range of needs and issues from evaluating payer insights to influence brand strategies to reviewing and leading the approval of new business cases for in-market brands.

Responsibilities:

• Develop Worldwide Market Access strategy for BMS' in-line and pipeline Oncology Medicines/assets by tumor/indication (e.g. OPDIVO®, YERVOY®, & Pipeline Assets (e.g. IDO, LAG3, & GITR).
• Work with Commercial, Medical, Business Insights and Analytics teams and local markets to ensure relevant insights obtained to formulate Market Access Strategy.
• Ensure registration trial designs are considered in the full evidence generation plans so that we BMS meets payer needs and requirement.
• To the greatest extent possible, ensure timely generation of evidence required to support Market Access Strategy post strategy development.
• Collaborate with the WW pricing strategy lead to adapt the Worldwide Pricing strategy for assigned BMS' Oncology assets maximizing both speed of access and long-term franchise value -based on Market Access strategy that considers commercial objectives and the market environment we anticipated at launch of the asset/combination of assets.
• Ensure that the Market Access Strategy' is supported by strong Payer Value Propositions articulating bold and differentiated messages on clinical, humanistic and economic benefits, and that those propositions are supported by strong bodies of evidence coming from both interventional, non-interventional, and real-world data in time for the first worldwide price negotiation at launch of the Brand or new Indication.
• In a competitive market like oncology, look to differentiate the BMR treatment using PRO and HEOR based evidence to support the Value Story.
• Work with BMS Regulatory to seek PRO claims in the product label.
• Drive the strategic input to inform executional plan of WW Market Access Strategy Core Market Access deliverables for assigned BMS Oncology asset or combination of assets.  
• Core Value Dossier.
• Health Economic Models.
• Global Communication and Publication Plans tied to the Market Access Strategy/Evidence Generation Plan.

• Partner with the WW Pricing Strategy Lead to effectively adapt the current IO franchise pricing strategy for new indications to optimize speed of access while maximizing long term portfolio value.
• Take part in Development Teams to ensure Market Access perspective incorporated into development plans.
• Monitor external environment and synthesize input to inform your strategy. 
• Ensure that all recommended Market Access activities comply with regulatory agencies, public policies/guidelines, and with corporate policies and procedures.
• If required, lead a team of people.  
• Effectively navigate matrix in order to develop and maintain positive relationships with other functional areas and Market Access colleagues in order to drive alignment, consistency where appropriate, best practice sharing, and flawless implementation of all Market Access activities.

Requirements:

• Strong understanding of the current and emerging global Market Access environment in Oncology Medicines.  
• Demonstrated ability to formulate future Market Access strategy scenarios and lead cross-functional teams, without formal authority, to act on these scenarios. 
• In depth Market Access experience from one or more countries required.
• Solid understanding of the biopharmaceuticals industry in oncology therapeutics;
• Minimum of 8-10 years’ experience with a strong track record in Market Access, Pricing or HEOR in a Global/WW or large local markets
• Demonstrated ability to change payer perception of a market and in particular to establish unmet needs and drive value perception.
• Knowledge of the Product Development and Commercialization Process.
• Launch/ commercialization experience desired.
• Demonstration of all BMS Behaviors, including Accountability, Innovation, Passion & Speed.
• Undergraduate degree required, MBA and/or post graduate degree required.

At Bristol-Myers Squibb, we believe that together we can make the difference. We want to do this by building professional teams who can create and innovate medicines that benefit doctors and their patients.

Our large-scale biologics manufacturing facility in Devens, Massachusetts, is expanding and there are a number of exciting career opportunities to join Bristol-Myers Squibb, one of the world’s leading BioPharma companies.

We’ve created one of the world’s premier biologics facilities, among the first sites in the industry to have a fully automated, integrated manufacturing control system that enables the plant to run virtually paperless. It is a site that combines biologics development with clinical and commercial manufacturing on a single campus – a true biologics center of excellence for the company where teams are encouraged to closely collaborate.

The Analytical Sciences & Technology group is committed to supporting our global biologics analytical network with reliability, integrity, active engagement, and cross functional collaboration. The Method Lifecycle Group in the Analytical Sciences and Technology department provides analytical oversight for the transition of programs entering the commercial space following clinical development.  The Method Lifecycle Group is looking for an experienced Associate Scientist with demonstrated expertise and hands-on experience with one or more of the following methods:  SDS-PAGE, CE-SDS, icIEF, ion exchange, size exclusion, and RP HPLC.  Good hands-on knowledge and experience with Empower chromatography DCS is required.  Knowledge of compendia methods would be a plus. The successful candidate will participate in defining new scientific approaches and data analysis in a commercial environment. Critical thinking, expertise in trouble-shooting of analytical methods and equipment as well as attention to detail is a must. This is a part laboratory based and part office based role with the expectation that majority of the time will be devoted to laboratory work.  Candidate will be required to plan & execute experiments as well as analyze data generated at other sites for method troubleshooting and improvements.  Ability to work collaboratively and across different functions in fast-paced environment is required.

Duties/Responsibilities:

• Provide technical input into analytical method revisions and improvements.
• Provide input during periodic review of method performance and work with team leader to execute remediation experiments and help implement changes to existing commercial methods
• Assist in authoring and review sections of regulatory filings as well as in responding to Health Authority queries regarding analytical methods.
• Work collaboratively across organization and sites for method readiness, transfer, performance and trouble shooting in commercial environment.
• Work closely with all AS&T team members to understand their deliverables to achieve organization goals.

QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:

• Demonstrated troubleshooting abilities and hands-on experience with one or more protein separation methods, including Electrophoresis, Chromatography, and UVIS spectroscopy based technologies (for example SDS-PAGE, CE-SDS, icIEF, different modes of LC)
• Familiarity with one or more protein characterization methods such as mass spectrometry, peptide mapping, and carbohydrate analysis.
• Practical knowledge of Empower CDS.
• Basic knowledge and understanding of regulatory guidelines (ICH, Compendia)
• Understanding of method validation and transfer.
• Experience of working with colleagues at remote sites.
• Understanding of GMP principles is expected.
• Ability to work independently.
• Strong written and communication skills and experience working in a matrix organization.

Education/Experience/ Licenses/Certifications:

Bio-therapeutic development & industry experience required: BS with 4+ years, or MS with 2+ years.

Physical Demands:

• This role requires office work, biochemical laboratory work, computer work, group meetings, and thus involves sitting, standing, walking, working with analytical instruments, repetitive motion including bending and lifting small containers/equipment’s.
• Due to safety concerns in a laboratory setting this role requires sufficient manual dexterity and sufficient vision.

Work Environment:

• Working in an analytical laboratory handling chemical reagents that may be hazardous (corrosive, toxic, flammable etc.).
• Office work, teleconferencing, computer work, participation in meetings requiring working in open office environment, working alone and working with/around others.
•  

Travel

• This position may require occasional domestic and international travel.

POSITION SUMMARY:

At Bristol-Myers Squibb, we believe that together we can make the difference. We want to do this by building professional teams who can create and innovate medicines that benefit doctors and their patients.

Our large-scale biologics manufacturing facility in Devens, Massachusetts, is expanding and there are a number of exciting career opportunities to join Bristol-Myers Squibb, one of the world’s leading BioPharma companies.

We’ve created one of the world’s premier biologics facilities, among the first sites in the industry to have a fully automated, integrated manufacturing control system that enables the plant to run virtually paperless. It is a site that combines biologics development with clinical and commercial manufacturing on a single campus – a true biologics center of excellence for the company where teams are encouraged to closely collaborate.

The Analytical Sciences & Technology group is committed to supporting our global biologics analytical network with reliability, integrity, active engagement, and cross functional collaboration. The Method Lifecycle Group in the Analytical Sciences and Technology department provides analytical oversight for the transition of programs entering the commercial space following clinical development and to lead technical transfer between laboratories.  The Method Lifecycle Group is looking for a Scientist with a strong background in driving method validation and technology transfer of analytical methods. The successful candidate will take a strong role in defining new scientific approaches, data analysis, facilitate method transfers and method qualifications and validations. Critical thinking, trouble-shooting and attention to detail is a must. This is a non-GMP, part laboratory based and part office based role. Candidate will be required to plan experiments as well as to analyze data generated at numerous sites for method validations and transfers. Ability to work collaboratively and across different functions in fast-paced environment is required. Hands on Qualification/ Validation experience in compliance with regulatory requirements is required.  Successful candidate must be able to manage and coordinate multiple tasks and timelines.

Duties/Responsibilities:

-Provide technical leadership of method validation. This includes partnering with analytical development to ensure method readiness for validation, writing validation protocols, gathering data generated by analytical development/QC labs and writing validation reports.  Provide technical oversight of method revision following validation.

• Lead method transfers to QC GMP labs within and outside of BMS.
• Assist in obtaining critical reagent supply and samples required for validation and transfer purposes.
• Assist in the periodic review of method performance and work with team leader to design and execute remediation experiments and implement changes to existing commercial methods.
• Review validation summaries in regulatory filings.
• Respond to Health Authority queries regarding method validation and transfer.
• Work collaboratively across organization and sites for method readiness, transfer, performance and trouble shooting in commercial environment.
• Work closely with all AS&T team members to understand their deliverables to achieve organization goals.

QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:

• Demonstrated experience with the validation of bioassay, immunoassay (impurities), and separation methods, including ELISA, Electrophoresis, Chromatography, qPCR, and UVIS spectroscopy based technologies.
• Extensive familiarity with USP/ICH guidelines.  Familiarity with international guidelines (EP, JP etc.) is desired
• Demonstrated experience of method transfer.
• Experience of working with colleagues at remote sites.
• Knowledge of GMP principles is desired.
• Ability to work independently.
• Strong written and communication skills and experience working in a matrix organization.

Education/Experience/ Licenses/Certifications:

• Bio-therapeutic development & industry experience required: BS with 6+ years, MS with 4+ years or Ph.D. with 2+ years of industry experience

Physical Demands:

• This role requires office work, biochemical laboratory work, computer work, group meetings, and thus involves the following.
• Sitting, standing, walking, working with analytical instruments, repetitive motion including bending and lifting small containers/equipment’s.

Work Environment:

• This role requires office work, teleconferencing, computer work, leading meetings and thus involves the following.
• Working in open office environment, working in laboratory, working alone, working with/around others.

Travel

• This position requires occasional domestic and international travel.

This position will work closely with the Corporate Secretary and the rest of the Corporate Governance and Securities team on corporate governance and shareholder engagement matters. Primary responsibilities include researching corporate governance issues, drafting presentations and other materials for the Committee on Directors and Corporate Governance, supporting the company’s shareholder engagement program, including coordinating shareholder meetings, drafting materials, and handling all aspects of Stockholder Services, including  stockholder inquiries and concerns, liaising with the Company’s transfer agent, maintaining and reconciling certain records relating to the company’s stock and dividends (including escheatment filings), and handling numerous duties relating to the Annual Meeting of Shareholders, among other things.  This position is also responsible for maintaining and updating beneficial ownership records for the Company’s directors and officers, preparing and filing Section 16 filings with the SEC, assisting with aspects of the Proxy Statement, and managing the quarterly trading restriction process.  The position will support operations for the Corporate Governance and Securities group, including working on budgets, accruals and financial projections. 

POSITION REQUIREMENTS:

• 4-6 years’ work experience and college degree required.
• Ideal candidate will have experience in corporate governance and/or shareholder engagement.
• The candidate must have the ability to deal with confidential information and use excellent judgment. 
• Knowledge of SEC Section 16 filings, i.e., Forms 3, 4 and 5, a plus.
• Candidate must also be detail-oriented and have excellent interpersonal skills, strong oral and written communication skills, and the ability to work well independently as well as part of a team. 
• Candidate should have capacity to focus on diverse projects with rapidly changing priorities.  Excel, Word, PowerPoint and analytical skills a must. 
• Night and/or weekend work required during peak periods.

Provide Quality assistance and oversight during start up of clinical manufacturing facility and manufacturing of clinical/commercial drug substance. Performs review and approval of records for the manufacture of in-process materials, drug substance and other GMP processes as required. Assists in the identification, generation and review of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.

This is a 2nd shift position working 2:00pm-10:30pm, M-F, including one 30-minute unpaid lunch break and two 15-minute paid breaks.

Responsibilities:

• Assures all electronic and paper documentation, which requires QA review is in compliance with corporate as well as site procedures, regulations, and other industry guidelines.
• Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs.
• Performs walkthroughs of the manufacturing facility and applicable support areas documenting observations and points of concern.
• Supports return to service walkthroughs and other walkthroughs per procedures as needed.
• Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing and support area related SOPs.
• Monitors and trends batch record error and right-first-time batch record review cycle times.
• Supports disposition and provides Quality Assurance management with quality indicator data. Supports the Quality review and closure of low risk investigations.
• Participates in the creation of a team based environment, promoting candor, collaboration, receptivity, clarity of purpose and goals, and high commitment to achieve business goals.  
• Demonstrates appropriate examples of compliance behaviors and attitudes. Supports on the floor activities in collaboration with Manufacturing and additional support groups as needed.
• Other duties as assigned.

Education/Experience/Skills:

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
• A minimum of 4 years of relevant experience in a regulated environment with at least 2 years focused on quality, validation or manufacturing operations.
• Knowledge of biotech bulk manufacturing, disposable technologies and analytical testing is highly desirable.
• Knowledge of US and EU cGMP regulations and guidance for clinical and commercial phase products is preferred.
• Knowledge of electronic and paper batch record systems, DeltaV, and other electronic systems applicable to laboratory test result generation, inventory management, investigations and equipment tracking and maintenance is desirable.

Scientist – Assays design & Data analytics

Job Description:
We are seeking a knowledgeable scientist with experience in assay design and assay data analytics. The candidate will be expected work with the assay and high-throughput production groups to help design and analyze data and interface with antibody lead generation group to interrogate and identify leads.

Specific Responsibilities:
• Establish automated assays and analyze data to identify leads.
• Partner with automated assay teams to facilitate assay data analysis and hit identification.
• Interface with antibody lead generation, biosensor, and biology teams and to identify leads.
• Excellent written and oral skills are necessary
• Accomplish goals under project team time lines

Requirements:
• Ph.D. in Cell Biology, Immunology, Molecular Biology, or related field with 2+ years, or MS with 5+ years, or BS with 10+ years of relevant experience.

• Extensive experience in homogeneous (HTRF), plate-bound, flow cytometry, and imaging based cellular assay formats.
• Experience in cell based immune activation assays is desirable.
• Experience in aggregating and analyzing assay data from automated systems, visualization of large datasets, and assign thresholds to identify leads is required.
• Knowledge and experience in antibody structure-function and hybridoma screening is desirable.
• Excellent time management, record keeping and organizational skills.
• Demonstrated ability to work in a multidisciplinary biologics discovery team.

Position Summary The Candidate Sourcing Specialist is part of a global team responsible for the full life- cycle of talent acquisition activities including: sourcing, screening, talent pipeline development, the selection process (interviewing, presenting a qualified short list of candidates, extending offers) and on-boarding successful candidates to Bristol-Myers Squibb (BMS).

The Candidate Sourcing Specialist is responsible for sourcing a diverse slate of qualified candidates to open positions and executing candidate engagement activities that result in dynamic candidate and hiring manager experiences.

• Execute sourcing, screening and engagement strategies to identify qualified candidates through various sourcing channels
• Provide a diverse slate of qualified candidates for open positions by making the initial contact with potential candidates and completing pre-screening activities
• Develop and maintain a network of contacts to help identify qualified, diverse and talented candidates
• Stay abreast of trends and innovative recruiting techniques in order to be competitive in state-of-the-art recruiting practices
• Maintain external focus on current market knowledge and competitor trends
• Build and maintain strong candidate relationships that result in superior candidate experiences
• Utilize BMS’s Employer Brand to effectively build relationships with external candidates and to ‘market’ opportunities within BMS
• Execute the full life-cycle recruiting process including sourcing, interviewing, presenting candidates, and negotiating offers
• Partner with Liaison Managers to understand the requirements for each specific position
• Partner with Total Rewards team to understand compensation structure and develop offers in line with that structure
• Responsible for data integrity within the Applicant Tracking System and other sourcing systems

Experience Desired

• 3 years recruiting experience, with experience in a Pharmaceutical/Biotech environment strongly preferred
• Demonstrated knowledge of candidate attraction and relationship building
• Demonstrated ability to execute full life-cycle recruiting activities including, but not limited to, sourcing, screening, presenting candidates, and negotiating offers
• Demonstrated ability to effectively partner and collaborate with peers to deliver the most qualified talent for the company
• Demonstrated ability to develop meaningful and long-term internal and external relationships
• Demonstrated ability to simultaneously progress a variety of active requisitions to meet established performance goals
• Strong understanding of technology and experience using talent acquisition systems, including Applicant Tracking, Candidate Relationship Management, social media, and other predictive tools

Minimum Requirements/Knowledge Desired:
• Bachelor’s Degree required + 3 years relevant experience
• Consulting skills/ impact and influence abilities/ strong stakeholder management skills
• Strong written and verbal communication skills, strong interpersonal skills

Bristol-Myers Squibb is recruiting an Associate Director for  Supplier Relationship Management.  The position will reside within the External Manufacturing ( ExM) Team located in New Brunswick, NJ. The position will report to the Director of the Americas Drug Product & Packaging Business Unit within External Manufacturing.  External Manufacturing is accountable for Bristol-Myers Squibb’s Contract Manufacturing Organizations (CMOs) globally spanning drug substance manufacturing,  drug product manufacturing and packaging of commercial products.  Domestic travel required (15 to 20%).

The Associate Director Supplier Relationship Manager (SRM) is accountable for the oversight and management of all Bristol-Myers Squibb (BMS) business with strategically important Contract Manufacturing Organization (CMOs).   Responsible for the relationship management and contract monitoring of drug substance, drug product and packaging CMOs to ensure uninterrupted supply.    

Essential Duties and Responsibilities:

• Proven Leader of strategically important and/or complex portfolio through a cross-functional virtual plant team in a matrix structure.
• Promotes team development, foster teamwork and build relationships within the Virtual Plant Team as well as within the wider GPS/BMS organization.
• Ability to lead ExM/GPS wide initiatives 
• Drive performance within the assigned CMOs to mitigate risks and drive continuous improvement to optimizing value.
• Manage, initiate and optimize positive strategic relations with the assigned CMOs through structured supplier relationship models.
• Develop and execute operational Budgets for the assigned CMOs and ensure alignment with External Manufacturing’s goals and objectives.
• Ensure the successful resolution of all issues that may impact timely supply of product and/or contractual obligations
• Effective Leadership of all operational activities to deliver supply from the CMOs.
• Contract Monitor for the assigned business
• Develop and execute CMO specific strategies and processes in line with ExM Mission Statement.
• Proactively identifies supply risks and proposes  strategies for approval and implementation to avoid or minimize their impacts
• Accountable for the performance of the assigned CMOs.  Responsible for reviewing and communicating CMO performance metrics and the development of the improvement plans as warranted. 
• Lead Business Review and/or Strategic steering governance
• Proactively identify supply risks and create and execute strategies to avoid or minimize their impact
• Accountable for CMO’ Business Continuity Risk Assessment
• Ensure Projects executed at the assigned CMOs are delivered in line with BMS requirements
• Collaborate with Finance for product cost standards, variances.
• Collaborate with Global Procurement throughout the supplier selection process including required supplier due diligence activities and contract negotiations to obtain the best total value (price, quality, service).
• Support the transfer and launch of new products.

Required Qualifications

• BS/MS/PhD in engineering, chemistry, pharmacy or related pharmaceutical sciences.  
• MBA, C.P.M. and Project Management Certifications desired.
• 10+ years of relevant experience in the pharmaceutical, biopharmaceutical or related industry.
• 2+ years as an Supplier Relationship Manager or similar role desired.

Required Competencies:

• Consistently demonstrates leadership qualities and energizes those around them.
• Proven ability to manage and influence a diverse stakeholder group including senior leaders
• Demonstrated high level of project management competency within the pharmaceutical industry.
• Demonstrated ability to work with and lead people/teams in a complex, dynamic environment to deliver value-added results to the organization.
• High level of knowledge of suppliers, industry trends and emerging players in global pharmaceutical CMOs.
• High level of knowledge of cGMP manufacturing operations of Pharmaceuticals and knowledge of associated regulatory requirements.
• Knowledge of sourcing methodology and vendor selection.
• Demonstrated ability to effectively communicate ideas and persuade others to accomplish challenging goals & objectives.
• Demonstrated team leadership skills and ability to work effectively with cross-functional & multi-location teams
• Excellent inter-personal, communication, and presentation skills required.
• Demonstrated financial and project management skills
• Demonstrated success negotiating complex supply and toll manufacturing agreements with CMOs.
• Experience of a culturally diverse workplace through international projects or global teams.  

Summary:

Accountable for assuring that the manufacturing operations (Parenteral and/ or Oral Solid Dosage) are performed in compliance with domestic and international cGMP regulations, and BMS policies and procedures and for providing scientific approach and Quality assurance direction to the approval of the GMP documents such as batch records, protocols, procedures, qualification, and validation reports. Enforce critical analytical thinking in the investigation management process specifically during root cause analysis, risk assessment evaluation and corrective and preventive actions determination to guarantee that gaps are properly addressed. Comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

Major Duties and Responsibilities:

• Interfaces directly with manufacturing operations to ensure that appropriate procedures are in place, through the execution of thorough reviews of procedures against practice.
• Leads and participates in the critical review of all documents associated with the manufacturing operations, release, packaging and relevant activities in the operations areas.         
• Ensures that deviation on documentation dealing with OOS or process parameters outside filing or validation are investigated and resolved by thoroughly reviewing timely corrective actions.
• Provides key technical guidance and oversight to manufacturing operations areas (OSD and / or Parenteral product) such as Compounding, Filling, preparation, capping, Inspection, compression and packaging to assure the appropriate cGMPs are in place through weekly operations audits.
• Ensures compliance of all procedures (SOP’s) to avoid potential regulatory and compliance issues.
• Provides scientific input into investigations management to assure root cause and CAPAs are aligned with the opportunities identified in order to perform a systematic approach.
• Supports actively the investigation process occurred in manufacturing area (OSD and Parenteral products) and warehouse, Microbiology laboratory, facilities and utilities providing coaching from Quality perspective.
• Provides guidance on gaps identified from the review and actively participates to determine potential remediation activities.
• Supports risk analysis process when a quality event has happened that cannot be solved immediately. This assessment needs to be completed to continue or prior to resumption of manufacturing process.
• Evaluates product impact and provide lot disposition recommendation when an investigation is completed as needed.
• Manages audit observation, investigations, change control and CAPAs records in Trackwise on timely manner.
• Provides technical guidance and quality assurance support in the transfer of new products and process to maintain quality standards.
• Participates in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), department staff, planning and change control board meetings as required.
• Evaluates  documentation compliance for all manufacturing and support areas such as CR’s, SOP’s, BR’s, BOM’s, WPP’s, qualification and validation Protocols, according with government regulations and BMS Policies.
• Provides support to the area QA Leader during the budget preparation activities.
• Evaluates department performance indicators and develop the appropriate corrective actions if needed.
• Assists management during internal and regulatory agencies inspections (FDA, DEA, MCA, etc).
• Develops sampling plans based on acceptance quality level criteria when additional or special testing is required.
• Performs trend analysis to provide recommendations in order to improve the process and /or the product quality.
• Supports Media Fill activities in order to assure that typical and atypical interventions are performed as established.
• Supports the Annual Product Review elements for Quality events of manufacturing and environmental monitoring.
• Evaluates and approve the instrumentation and equipment calibration records and critical area engineering drawings.
• Reviews and approves equipment, utilities and facilities qualification and system life cycle documentation.
• Reviews and approves all process, product and computer systems validation protocols and reports, change control documentation, redressing / reprocessing / rework operations, investigation reports related to manufacturing process and microbiology laboratory, and Annual Product Quality Review (APQR’s) elements.
• Approves or reject procedures impacting drug products, raw material or packaging components.
• Verifies compliance with BMS Policies and Guidelines.
• Participates as quality representative or liaison in site projects Performs pre-operational review form approval in the manufacturing and packaging area.
• Performs shop floor walk through audits and challenge adherence with area procedures, coaching and Quality Support in alignment to the business unit to optimize compliance and efficacy.
• Verifies consistency with other site procedures and/or specifications.
• Reviews and approves investigations related to process, products, utilities, microbiology laboratory and calibrations.
• Approves Corrective and Preventive actions (CAPA’s).
• Approves or reject specifications impacting drug products, raw material or packaging components.
• Ensures there are effective systems for the maintenance and calibration of equipment and approves of calibration requests.
• Ensures the designation and monitoring of storage conditions for quarantine materials and products.
• Reviews and approves procedures related to process, products, utilities, and laboratories.
• Maintains management informed (via frequent written reports) of any problem that might affect the quality and/or timely release of materials

Based on the business needs and from time to time, the incumbent could perform these tasks in addition to the major duties and responsibilities of the role:

Knowledge/Skill:

• Performs batch characteristic review and approval on timely matter.
• Supports department management in data presentations and special projects. Performs cMAT review and approval.
• Supports SAP Corporate initiatives and projects.
• Supports MD&C (Material Differentiation and Control) initiatives.
• Perform SAP Inspection Lot review and update.
• Supports change on system structures based on approved Packaging Specification, data received from Manufacturing, QC, Planning, and Finance.
• Supports site data quality standards monitoring and performs corrective actions related to data quality audit results.
• Coordinates with QA Scientists the review and approval of batch records. 
• Bachelor Degree in Science (Chemical, Engineering, Biology, Pharmacy or Microbiology) with six (6) years of experience in Quality Assurance responsibilities in a pharmaceutical industry, or Doctoral Degree (PhD) in Pharmacy with valid License in Pharmacy (Good Standing and / or without Restrictions of Puerto Rico Board of Pharmacy).
• Knowledge of manufacturing operations of Oral Solid Dosage and Parenteral Products Manufacturing
• Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use
• Fully bilingual (Spanish/English) communication skills, both written and verbal.
• Self-motivated, creative and team work oriented
• Technical and scientific capability to make firm decisions and recommendations
• Excellent interpersonal skills and the ability to interact with people at all levels
• Effective communication Skills
• Sense of urgency and analytical thinking
• Proficient knowledge of computer systems (Microsoft Office etc.) and applications like Trackwise and SAP
• Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results
• Proficient knowledge of problem solving and root cause analysis methodologies (i.e. Kepner Tregoe)
• Willing to work irregular hours, rotative shifts, weekends and holidays when needed

Position Summary

As a member of the Internal Manufacturing Biologics Leadership Team, the General Manager acts with the highest level of integrity to support the business by driving quality and compliance excellence, cost optimization, talent development, and ensuring reliable product supply for the Manufacturing Facility located in Manati, PR.

Leading strategy development and execution

Utilizes insights from an integrated understanding of business and local external environment to provide strategic input into creation of site and product supply strategies.
Develops and implements site strategy and plans that are aligned with the broader organizational strategy.
Knows the local economic, market, regulatory, environmental and industry trends and uses trend data to maximize opportunities and minimize risk exposure.
Champions Operational Excellence by institutionalizing changes in process, practices, business models, governance, etc.
Builds appropriate, strategic relationship with external partners.
Anticipates risk and builds contingencies to help mitigate impact.

Delivering financial commitments

Effectively manages P&L (bottom line) to optimize financial performance.
Delivers financial commitments to optimize short term performance and long term growth while ensuring compliance with all laws, regulations, and company policies.
Appropriately allocates resources to align with supply strategies.
Conducts financial reviews to monitor business performance.
Establishes appropriate budget goals aligned with the internal strategy and plans.
Enhances and ensures financial forecasting / projection accuracy.
Understands external financial pressures (including cost of goods), anticipates potential effect on business and takes appropriate action.

Influencing external environment

Represents BMS interests with important external stakeholders as appropriate and aligned with corporate direction, e.g. government and regulatory officials, industry and industrial associations, and the media.
Ensures effective management of the relationship with external third parties, where involved. Maintains company’s rights under the contractual relationship and complies with contract in conduct of operations.
Strengthens and improves the image of BMS and the pharmaceutical/health care industry.

Integrating the matrix through vertical and horizontal alignment

Creates a unified and seamless cross-functional leadership team that works together to achieve organizational objectives.
Builds personal credibility and strong working relationships, breaks barriers and influences across organizational and/or geographical boundaries leading to efficiency, effectiveness, and agility for optimized organizational performance
Champions Enterprise Mindset fostering collaboration between cross-functional teams and establishing sound partnerships with global functions
Co-leads the Puerto Rico One BMS approach along with peer GMs
Ensures the right people and resources are in place and optimally allocated to achieve results.
Establishes and works within appropriate governance models.
Creates an environment that fosters accountability, innovation, learning, knowledge sharing and constructive disagreement.
Makes decisions with appropriate balance of alignment, speed, and rigor.

Institutionalizing a culture of compliance and high performance.

Communicates and sets the example for why compliance is integral to business success and achieving competitive advantage in the marketplace.
Establishes and monitors the financial and business controls and processes to follow internal and external rules and regulations for or within the legal entity.
Creates and drives a culture of continuous improvement focused on maximizing efficiencies and delivering operational excellence.

Attracting, developing and retaining diverse talent.

Exemplifies the BMS Behaviors and leadership capabilities at all levels in the organization and amongst his/her peers
Serves as a role model providing feedback and coaching across all functions
Conducts short and long range talent planning to ensure readiness of talent to execute future organizational objectives
Establishes an efficient and effective organizational structure with clearly defined roles and responsibilities; drives short and longer term workforce planning, leveraging on external and internal best practices to achieve organization effectiveness
Works across functions to build organization and individual capability, utilizing BMS programs and practices as applicable (e.g. talent reviews, functional excellence programs, career development, etc.)
Is visible and communicates with people at all levels
Develops strong relationship with employees and provides open and clear communication ensuring a clear path for issue resolution

Leadership Capabilities:

Enterprise Mindset

Uses knowledge of external and internal business factors to inform decisions.
Ensures teams are responsible for contributing beyond their own function.
Proactively connects teams, networks and individuals in order to increase organizational performance.
Creates integrated, long term strategies that have the potential to transform BMS and the industry.

Authentic Leadership

Fosters a climate of self-awareness and open dialogue; speaks to personal struggles and how they deal with/overcome them.
Understands others’ styles and approaches and knows how to leverage and value them.
Holds others accountable for doing the right thing, even when it requires some personal risk.
Change Agility

Identifies and creates distinctive, game-changing opportunities that lead to higher organizational performance.
Has the data and rationale to see the future of the industry, frames it in an understandable way and wins support for change in a fast-paced environment.
Thinks 3-5 years ahead, develops contingency plans for multiple scenarios.
Hires, develops and rewards change agents, welcoming and encouraging those who challenge, to the status quo and test their own thinking.

Talent Developer

Uses understanding of BMS strategic requirements to identify future talent needs and puts plans in place to address.
Continuously scans external networks for talent with key capabilities for BMS and is proactive in creating opportunities to attract external talent.
Proactively facilitates cross-functional assignments or opportunities.
Provides coaching and support over the long term. Encourages appropriate risk taking in one’s development and supports learning from challenges and setbacks.

Required Qualifications and Experience

15+ years of manufacturing operations experience in a complex global environment with a track record of establishing productive relationships internally and externally
BS/BA in Technical Field (Biology, Microbiology, Chemistry, related life sciences or engineering) with advanced technical degree, MBA, and/or equivalent experiences desirable.
Leadership experience in one or more functions (e.g. Production, Quality, Supply Chain, and Manufacturing Technology)
Leadership experience in different manufacturing environments
Experience working in and with multiple geographies preferred
Understanding of regulatory environment and challenges including experience interfacing on government/ policy issues
BioPharmaceutical industry experience a plus, aseptic drug product manufacturing desired.
Experience in being the lead change agent in complex transformational activitiesConversational in both Spanish and English
Ability to travel on an as-needed basis