Bristol Myers Squibb (BMS) has one of the richest biopharmaceutical pipelines in the industry. We discover, develop, and manufacture lifesaving and life altering drugs in cancer, hepatitis C, heart disease, and other therapeutic areas. BMS also has one of the most reliable supply networks and our clinical operations program is among the best and busiest anywhere. We are a company that is forward thinking, a company in which diversity and inclusion are at the forefront of how we view our talent and how we work. Our science is second to none and the transformation work underway will enable us to continue to lead our peer group.

Bristol-Myers Squibb is looking for a Clinical Site Manager based in Uxbridge, UK. Office based

Responsibilities:

• Independently monitors the progress of assigned investigator sites by maintaining close contact with site personnel and internal project team. Coordinates and maintains effective communication (oral, written) and serves as a BMS contact for the investigator. Provides feedback and status updates to internal stakeholders on an ongoing basis. Demonstrates an understanding of the overall project goals, the indication studied and the purpose of the assigned study in meeting the objectives of the project. Works closely with other study team members in the coordination of study activities to meet the appropriate timelines at the site/protocol level.
• Independently manages activities at the site and monitors study progress by providing guidance as required and by close collaboration with other key stakeholders (e.g. Medical Monitor, Protocol Manager, Clinical Trial Associates, Contract Administrators, Clinical Data Quality Managers and Site Monitor(s)) as applicable. Documents substantive contacts concisely and in accordance with SOPs.
• Identifies potential issues at the site or protocol level and suggests resolutions. Answers and resolves routine or site related questions independently. Knows when to defer difficult or unresolved issues to the appropriate team member.
• Responsible for completion of EPC from clinical perspective for the assigned sites.
• Independently disseminates information to appropriate BMS team members to ensure timelines are met (e.g. Site Manager(s), Clinical Data Quality Manager(s), Site Monitors, Clinical Trial Associate, Contract Administrators). Proactively identifies and resolves issues noted during site management which impact the overall protocol timelines and informs the appropriate BMS team members (e.g. Protocol Manager, Site Monitors, Line Manage) and coordinates follow-up.
• Ensures program level standards are applied at the protocol level from study start-up to data base lock. Shares experiences and best practices through coaching and feedback.
• Skilled in the use of technology. Is able to function independently in addition to coaching other team members. Effectively uses available tools and systems to gather information needed to manage site activities, generate reports and to provide feedback to the appropriate BMS team members (e.g. Site Monitor(s), Line Managers, Hub Unit Manager, Protocol Manager and Medical Monitor).
• Communicates information and issues (globally or on a country level) to Site Monitors, Site Managers, Clinical Trial Associates, Clinical Data Quality Manager(s), Line Managers, Hub Unit Manager, and Protocol Manager to ensure that site management activities, protocol execution and study documentation are in compliance with study timelines, ICH-GCP guidelines, BMS SOPs and local regulatory guidelines or regulations.
• Demonstrates a thorough understanding of all steps in the clinical research process. Coordinates initial and ongoing training of Investigators, site personnel, vendors etc, and collaborates with other relevant internal stakeholder as necessary.
• Provides on-going training and mentoring to team members through a mentoring process using informal and/or formal presentations. Serves as a resource for colleagues. Understands how the issues of a single study can impact the overall project and contributes to establishment of best practices through coaching and feedback.
• Leads or participates as an active member of cross functional teams, task forces, or local and global initiatives

​

This job might be for you if you have:

• Experience as an Associate Clinical Site Manager/Lead SMN/Senior SMN experience or equivalent experience within the pharmaceutical industry.
• Experience with aspects of project management.
• Experience in the conduct and management of Investigator sites from start-up to database lock within expectations set by management.
• Experience in effective implementation of clinical plans/documents and document preparation.
• Previous experience working in a team environment within a matrix organization.
• Knowledge equivalent to that attained with a Bachelor’s degree in Life Sciences, Allied Health, Pharmacy
• Nursing and clinically related or relevant experience.
• Thorough understanding of ICH-GCP guidelines and local regulatory guidelines or regulations as they apply to protocol/site management.
• Knowledge of general clinical research including Investigator site issues, important milestones and strategies to ensure timelines are met.
• Knowledge of the pharmaceutical industry and of the pre-clinical, clinical, regulatory and commercial components.
• A detailed understanding of project planning and management methods.
• Knowledge of Database Management Systems.

Why should you apply:

• You will help patients in their fight against serious diseases and you will increase the survival of more people with cancer
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a very competitive salary and a great benefits package including an annual bonus, pension contribution, family health insurance, 26.5 days annual leave, life insurance, on site gym and gain-sharing bonus.

Interested?

Apply now by clicking the Apply button, or email me at paulina.piesta@bms.com  for more information.

This position is for a Specialty Retail Sales Representative located in Houston, TX. 

Sales candidates must be able to understand and apply knowledge of pertinent health care industry trends, sales trends, market dynamics, competitors, applicable laws and regulations, and health care payer environment, and analyze each of these factors in the development of actionable business plans and in daily execution of sales calls, within compliance guidelines.  Develop and implement territory plans that identify and prioritize activities and resources to accomplish short and long-term sales and business goals.

An accountable self-starter who can develop deep customer insights, build and maintain strong professional relationships with physicians (primary care and specialists), pharmacists, nurses, office staff and other health care providers in the patient care continuum.  Appropriately leverage resources and apply sound account management skills and perseverance to secure customer access and maximize selling time.  Utilize deep understanding of disease states, BMS products, and as appropriate, relevant competitor products to tailor interactions with specific customers.  Excellent communication skills- verbal and written- including the ability to present to groups.

Collaborate across the Cardiovascular sales organization, CV Institutional Sales Representatives, cross functional teams and where appropriate alliance partners.   Work within matrix team to identify opportunities and develop appropriate tactics and strategies. Drive market share growth and maximize sales performance within the indicated use and approved patient types.

Bachelor's degree or equivalent is required.  Minimum of 5 years of sales experience is preferred.  Demonstrated success in medical profession is advantageous.

A strong customer focus and analytical skills to identify and prioritize business opportunities is required.  Proven track record in delivering results and developing innovative approaches in evolving markets.  Previous new product or concept launch experience desired.  Ability to learn, apply, and grow disease state knowledge is  required.  Ability to effectively communicate technical and scientific product and disease information to a variety of customers in multiple settings.  Technical aptitude to learn and apply new technologies to manage a territory is required. 

Management retains the right to change the job specifications (may include grade level and salary range) and provisions of this job as appropriate.  In addition, we reserve the right to place candidates in positions at levels commensurate with their depth of knowledge around the following competencies:  Product and Disease State Knowledge, Market and Industry Knowledge, Sales Resource Utilization, Selling Skills, and Business Planning.

As this position requires operation of a Company-provided vehicle, offers of employment are contingent upon the candidate meeting the requirements of “Qualified Driver,” as determined by the Company in its sole discretion, including but not limited to the following: 1) at least 21 years of age; 2) a driver’s license in good standing issued by your state of residence; and, 3) a driving risk level deemed acceptable by the Company. 

Possess a high level of ethics and integrity.  Adhere to all applicable laws, regulations, and BMS policies.

Oncology Field Force Learning & Development (FFL&D) is currently looking for a talented training professional who possesses the skills needed to ensure both the immediate and long-term success of the US Oncology FFL&D Team. The selected candidate for this position will assist in the development of a tumor specific curriculum to be utilized by front line sales District Business Managers (DBMs), Institutional Tumor Specialists (ITS), as well as Community Product Specialists (CPS).

The Field Force Capability Hub is the catalyst for empowering the field force to drive transformative customer experiences that give patients hope. The Oncology Field Force Learning & Development (FFL&D) team is a dynamic training organization that is executing on excellence in building expertise and knowledge for our US Oncology sales teams. As a Training Manager, you will be working amongst the best in your profession and have the opportunity to collaborate with talented and dedicated professionals committed to advancing learnings in the Oncology space.

Who you will work with:

This Manager position reports to an Oncology FFL&D Associate Director who reports to the Head of Oncology FFL&D. In this role, the Manager will work collaboratively across a fast paced and complex matrix organization which includes the Oncology Business Unit, Technology Training Solutions and WW Training & Design. Specifically, the Manager will work in close partnership with colleagues from several functions (e.g. Sales, Marketing, Sales Operations, Medical, Legal, Compliance, etc.) to appropriately address business needs and ensure that we deliver on our objective of demonstrating value to both customers and patients.

Primary responsibilities:

Strategic planning and development of a comprehensive Sales training curricula focused on a specific tumor type for use during training classes, POAs and other national/ regional/ district meetings.

Coordination across the Oncology matrix and cross-functional team to ensure all training materials meet the goals and objectives of both Sales and Marketing teams.

Ensure training resources (e.g. materials, workshops, competitive job aids, etc.) meet all regulatory, legal and compliance requirements for assigned individual projects and initiatives.

Deployment and delivery of a tumor-specific curriculum to the Oncology Sales Force inclusive of: selling skills, clinical disease state knowledge, competitor and market landscapes, and Business of Oncology.

Partner with Oncology preceptors, FFL&D colleagues, Sales management, and Marketing management to consistently implement results-focused, performance-based, standardized training and development processes.

Potential to work with and/or manage external vendors and internal personnel to ensure the successful design and roll-out of assigned training programs and projects.

Assess and analyze the effectiveness of assigned training programs and initiatives.

Identify and utilize innovative technologies to facilitate adult learning, pull through of training and virtual training capabilities.

Qualifications:

Bachelor’s degree or equivalent required; Master’s or Doctorate degree preferred

Minimum of 8 years Pharmaceutical industry experience preferred

Minimum of 5 years of Pharmaceutical customer facing experience required; minimum 2 years Account Management/Specialty Segment role preferred

Minimum of 2 years Oncology Training or Product Management experience required; instructional design experience preferred

Job Description Manager, Oncology Field Force Learning & Development

Demonstrated strong product & disease state knowledge; Hepatocellular Carcinoma and/or Gastrointestinal Cancer therapeutic area experience preferred

Effective communication, facilitation and presentation skills

Proven performance with a track record of meeting or exceeding goals

Demonstrated ability to effectively manage multiple projects

Demonstrated ability to develop and implement key learning objectives, strategies and tactics

Problem solving and solutions-oriented team player

Strong business analytics to understand and analyze business and market drivers, develop, execute and adjust business plans

Experience operating within a highly complex cross-matrix environment; ability to connect and collaborate with key matrix team members including Marketing, Sales Operations, Commercial Sales, Medical, Legal, Regulatory, & Compliance

Demonstrated curriculum design, understanding of adult learning principles; including previous experience leading new hire and skill training workshops

Impact driven with high learning agility and keen ability to prioritize

Proficiency in Microsoft Office Power Point, Excel and Word and other applications

Ability to travel for multiple meeting engagements (e.g. Managers Meetings, National Plan of Action Meetings, various Training Initiatives, etc.)

This position is for a Specialty Senior Retail Sales Representative located in the Louisville East territory.

Summary

Sales candidates must be able to understand and apply knowledge of pertinent health care industry trends, sales trends, market dynamics, competitors, applicable laws and regulations, and health care payer environment, and analyze each of these factors in the development of actionable business plans and in daily execution of sales calls, within compliance guidelines.  Develop and implement territory plans that identify and prioritize activities and resources to accomplish short and long-term sales and business goals.

An accountable self-starter who can develop deep customer insights, build and maintain strong professional relationships with physicians (primary care and specialists), pharmacists, nurses, office staff and other health care providers in the patient care continuum.  Appropriately leverage resources and apply sound account management skills and perseverance to secure customer access and maximize selling time.  Utilize deep understanding of disease states, BMS products, and as appropriate, relevant competitor products to tailor interactions with specific customers.  Excellent communication skills- verbal and written- including the ability to present to groups.

Collaborate across the Cardiovascular sales organization, CV Institutional Sales Representatives, cross functional teams and where appropriate alliance partners.   Work within matrix team to identify opportunities and develop appropriate tactics and strategies. Drive market share growth and maximize sales performance within the indicated use and approved patient types.

Possess a high level of ethics and integrity.  Adhere to all applicable laws, regulations, and BMS policies.

Qualifications

Bachelor's degree or equivalent is required.  Minimum of 5 years of sales experience is preferred.  Demonstrated success in medical profession is advantageous.

A strong customer focus and analytical skills to identify and prioritize business opportunities is required.  Proven track record in delivering results and developing innovative approaches in evolving markets.  Previous new product or concept launch experience desired.  Ability to learn, apply, and grow disease state knowledge is  required.  Ability to effectively communicate technical and scientific product and disease information to a variety of customers in multiple settings.  Technical aptitude to learn and apply new technologies to manage a territory is required. 

Management retains the right to change the job specifications (may include grade level and salary range) and provisions of this job as appropriate.  In addition, we reserve the right to place candidates in positions at levels commensurate with their depth of knowledge around the following competencies:  Product and Disease State Knowledge, Market and Industry Knowledge, Sales Resource Utilization, Selling Skills, and Business Planning.

As this position requires operation of a Company-provided vehicle, offers of employment are contingent upon the candidate meeting the requirements of “Qualified Driver,” as determined by the Company in its sole discretion, including but not limited to the following: 1) at least 21 years of age; 2) a driver’s license in good standing issued by your state of residence; and, 3) a driving risk level deemed acceptable by the Company. 

The role of Manager of US Commercial Regulatory Affairs requires the ability to apply scientific and regulatory advice and risk assessment for the development of promotional materials for an assigned product/therapeutic area in order to help meet the Company’s objectives.  Individual, along with supervisor input, will ensure materials are consistent with BMS guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidances.

Responsibilities include:

• Provides regulatory advice and risk assessment to Commercial Teams, Medical Affairs, and Public Affairs on all promotional materials including concepts, disease awareness, and institutional campaigns on assigned products/therapeutic area
• Provides solution oriented and innovative advice to meet the Company’s objectives and goals
• Ensure regulatory compliance on promotional materials with approved labeling and/or FDA guidances
• Ensure regulatory compliance with sub part e and 2253 regulations
• Assist with training for Commercial teams on sub part e and 2253 regulations
• Monitor and maintain knowledge of the evolving regulatory landscape to provide the most current regulatory advice and risk assessment
• Collaborate and build relationships with internal customers; including Commercial, Medical, Legal and Compliance
• Assist in interactions with the Office of Prescription drug Promotion (OPDP) for assigned product/therapeutic area, including drafting communications for  advisory submissions and sub part e binder submission
• Participate and provide input during product labeling development and submissions
• Work with management to provide advice on and ensure that changes in US PI are reflected in current promotions and advertising
• Provide input on process improvement and BMS guiding principles, as needed
• Handle other duties and/or special projects as assigned

Position Qualifications:

• Bachelors Life Science degree preferred; advanced degree ideal (MS, PhD, PharmD)
• Candidate should have a minimum of 1-2 years Regulatory promotional review experience.
• Candidate should have experience providing strategic direction to interdisciplinary teams on promotional materials and activities for marketed products and strong interest in FDA advertising and promotional practice regulations including guidance(s).
• Broad “hands on” related pharmaceutical experience (prefer 5 years pharmaceutical industry experience) and actual FDA regulatory experience
• Organizational skills and ability to pay attention to details
• Excellent verbal and written communication skills
• Excellent interpersonal skills, flexibility, and ability to communicate effectively with cross functional teams

Ensures the continue operations of all Process Equipment including programming and ongoing maintenance for Production, Facilities and Utilities Areas. Supports all equipment process control and automation systems assuring process control and automation systems operations are maintained considering plant policies, procedures and FDA regulations under cGMP’s and other regulations applicable. Supports process integration for major computer system applications that impact the (Production, Facilities and Utilities) Areas. Performs  process equipment  analysis  and recommends improvements to existing processes through the use of state-of-the-art computer technology and participates proactively as a team member of implementation projects for new integrated business application and process automation, providing consulting advice in the use and management of technology.

d)   Installs, configures, troubleshoots, and maintains process control and automation systems. These systems include, not limited

                 to: PLCs, SCADAs/HMIs, microcontrollers, single loop controllers, DCS, interfaces and report development.

Provides user’s training and continuous support to assure proper use of the software applications following established operational procedures and user support during problem solving situations associated with systems implementation and; also assess and prepares development training in target areas in order to increase technician’s proficiency in current technology and assignments to support reliability program (e.g.  FMEA/FMECA documents, root cause analysis, etc.) Reviews computer related software applications or computer programs to ensure that plant standards are met and that programs are capable of being integrated with other software applications as required. Troubleshoots and maintains process control and automation systems such as PLCs, SCADA, DCS, and Fourth generation languages for interfaces and reports development in the Manufacturing, Facilities and Utilities areas.

Evaluates, originates and closes change control documentation assuring the validated and compliance state of the environments and performs documentation of maintenance activities using Computer Maintenance Management System (CMMS) according to procedures.

Performs project management functions for the execution, implementation and start-up of process control and automation systems. Evaluates workload and capacity of process control and automation systems to determine feasibility for expanding, upgrading or enhancing operations. Reviews and tests programs to ensure that they meet manufacturers recommend requirements for hardware and software at the personal computer and/or host computer system level. Performs changes to applications, configurations or programming to assure software works as expected before installing it in the user environment. Provides project status through the use of project plans and perform best efforts to achieve projects milestones within the pre-established due dates and; provides alternatives and problem solving initiatives during possible project delays or possible showstoppers. Prepares or provides support in the preparation of procedures (e.g., Systems Life Cycle) and defines standards for software automation, system integration and defines the strategy for plant automation and process integration through an analysis and design/re-design of current systems and processes. Prepares and/or reviews process control and automation systems related procedures, such as: Backup/Restore, Disaster Recovery and/or maintenance activities (i.e. PMs and troubleshooting guides). Contacts hardware or software vendors (if applicable) to report problems and, coordinates and implements vendor recommendations when approved or accepted by the functional area owners. Assures reported problems are solved by implementing corrective actions like (but not limited) users retraining, changes to existing SOPs, applying software fixes or hardware fixes, information resources colleagues recommendations, etc. These activities must comply with current applicable change control procedures. Provides sound problem solving techniques to resolve issues and qualification problems. Assists in the management of Capital Appropriation Requests (CAR’s), and timeline of process control and automation systems projects and implementation and/or initiatives.

The Wellbeing Coordinator develops programs which are designed to support employees and their families as they adopt and sustain behaviors that reduce health risks, improve quality of life and enhance personal effectiveness. 
The Wellbeing Coordinator uses thought leadership, project management, analytical and relationship skills to engage and drive our people to take action for their health and happiness and to ensure maximum return from our multiple vendors.
As the primary contact for BMS’s Wellbeing initiatives, the Coordinator will be responsible for the design, development, and implementation of the Global BMS Wellbeing strategy.  They will be expected to implement the current strategy as well as identify future Wellbeing trends.  The coordinator will evaluate these trends and arrive at creative solutions for BMS Wellbeing programs.  Additionally, they will be expected to lead initiatives that focus on Wellbeing coordinating these initiatives with EOHSS, Total Rewards,  and other BMS cultural initiatives.

• Responsible for overall Wellbeing program design and implementation of a global Wellbeing strategy
• Assist with  design and development of the Wellbeing strategic plan
• Manage the Wellbeing Champions network
• Manage the current vendors for Living Life Better, fitness centers, EAP, mobile mammography, massage therapists, energy management, and National Family Care Program
• People Strategy Liaison for the Child Development Centers
• Work with Total Rewards to implement Financial Wellbeing program
• Work with EOHSS to link Wellbeing with Safety program
• Evaluate the participation in  and results of current programs and recommend changes and enhancements
• Maintain knowledge of developing wellbeing trends and research in the field of employee health and productivity.  Recognize potential implications for Bristol-Myers Squibb and recommend new programs based on evidence.

Qualifications:

• Bachelor’s degree in a health-related field preferred
• Experience in wellbeing strategy, planning and delivery
• Vendor management experience
• Prefer solid understanding of health promotion, worksite wellness, and behavior change practices
• Prefer experience in developing, implementing and managing corporate wellness programs
• Project management experience a plus

Excited to grow your career?

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

This position is part of the IT Service Management team and plays a key role in overseeing the Configuration Management Database (CMDB), a vital foundational component of the IT Service Management practice at Bristol-Myers Squibb.  The CMDB supports core service management processes – Incident, Problem, Change & Release, Service Request, Application Portfolio Management and others such as IT Financial Management. The person in this role will have responsibility for ensuring its accuracy, completeness and evolution. The Configuration Manager position is suited for someone with a passion for data integrity.  This position involves the following responsibilities.

Expectations of the role include the following:

• Take a lead role in analyzing the CMDB data to highlight anomalies and errors and to identify opportunities
• Apply skills as a seasoned, experienced professional with a full understanding of industry practices and established policies and procedures to perform trend analysis and guide SACM strategy. 
• Lead CMDB data governance board meetings with Domain Owners to review status reports, highlight issues, monitor data quality progress, and provide guidance
• Provide consulting services within the team and to other BMS departments in recommending corrective and preventive actions
• Define CMDB data quality reports to ensure accurate and up to date information
• Work with CI type owners to define and implement remediation plans
• Maintain CMDB Data Model
• Curate SACM articles in the knowledge management repository
• Lead process interactions between SACM and other processes
• Support SACM Process Owner as needed; proactively identify process improvements
• Provide input into Service Management Office, present findings and make recommendations as needed

Position Requirements :

• Excellent interpersonal and communication skills; ability to form strong relationships within a matrix organization.
• Good understanding of service management principles including management of configuration items (CIs), thinking in a service context, and defining outcomes-based delivery.
• Must be detail oriented, analytical, and demonstrate ability to work in ambiguous environment. Must be self-directed with proven ability to make mature decisions supported by thorough data analysis.
• Project management skills a plus
• BA/BS degree in Computer Science preferred
• 5-6 years’ experience in IT operations
• ITIL v3 Foundation certification required; Service Transition Capability certification preferred
• Experience with the ServiceNow platform preferred

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.  The Method Lifecycle Group is looking for an experienced Scientist with demonstrated expertise and hands-on experience in the imaged capillary isoelectric focusing (icIEF) techniques plus one or more additional separation methods.  Knowledge of compendia methods would be a plus. The successful candidate will take a leading role 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. 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 oversight and ownership of icIEF based and other analytical methods.
• Provide technical oversight of method revisions and improvements.
• Provide expert input during periodic review of method performance and work with team leader to design and execute remediation experiments and implement changes to existing commercial methods.
• Author and review sections of regulatory filings.
• Respond 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 icIEF and one or more protein separation methods, including Electrophoresis, Chromatography, and UVIS spectroscopy based technologies.
• Familiarity with protein characterization methods such as mass spectrometry, peptide mapping, and carbohydrate analysis.
• Knowledge and understanding of regulatory guidelines including all major international guidelines (USP/ICH, EP, JP etc.).
• Experience 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 6+ years, MS with 4+ years, or Ph. D.
• Industry experience in analytical development or commercialization of biopharmaceutical products preferred.

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.
• Due to safety concerns in a laboratory setting this role requires sufficient manual dexterity and sufficient vision.

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 may require occasional domestic and international travel.