Principal Scientist, Pharma Manufacturing Science and Technology (MS&T)

at  BristolMyers Squibb

WORKING WITH US

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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 with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

Qualifications, Knowledge and Skills Required:

• Must have in-depth knowledge of bulk drug product - recognized as a technical leader and subject matter expert Oral Solid Dosage (OSD), Semi-solids, Liquids, Sterile/Aseptic products manufacturing.
• Experienced with use of statistical software to analyze process related data to determine process capability or for troubleshooting purposes.
• Proficient in the technical transfer of products to CMOs within budget and according to project timeline. Demonstrated ability to project manage one or more tech transfer projects with minimal supervision.
• Substantial experience of manufacturing support activities (change control, investigations, process optimisation)
• Excellent verbal, written communications and presentations skills, including excellence at writing complex study plans and scientific reports; informed line management about the critical issues related to product manufacturing and process / package validation where appropriate.
• In depth understanding of regulations concerning cGMP, manufacturing/packaging/artwork, validation, quality systems, equipment innovations, upgrades, and instrumentation.
• Ability to work on own and as part of a team and to drive issues to resolution.
• A degree in science or a related field with a minimum of 7 years relevant experience.
• Proven record in pharmaceutical technology, technology transfer, process development and manufacturing support/activities.
• Experience of statistical software.
• Demonstrable experience of analytical method validation.
• Ability to interact at all levels of the organisation with proven influencing ability e.g. Regulatory, Supply Chain, CMO, etc. to achieve goals.
• Ability to understand business implications of technical decisions

BMS External Manufacturing is looking to recruit on a permanent Contract Principal Scientist, Pharma Manufacturing Science and Technology (MS&T), reporting to Director, MS&T Pharma DP Commerical.
The Pharma Manufacturing Science and Technology (MS&T) Senior Manager / Principal Scientist provides technical support to the External Manufacturing Organization and (ExM) Contract Manufacturing Organizations (CMOs).

Key Duties and Responsibilities:

• Support CMO/vendor selection process - preparation of technical information packages, participation in due diligence and site assessments, technical evaluation of Requests for Information (RFIs) and Request for Proposal (RFPs).
• Accountable for technology transfer to contract manufacturing organisations.
• Support regulatory activities associated with changes to assigned products .
• Support operational management of CMO as per Virtual Plant Team (VPT) governance structure
• Provide ongoing technical support to ExM / CMO to ensure compliance and security of supply - metrics review, investigation close-out, change control review, Annual Product Quality Review (APQR) review, process improvement. Implement / OPEX initiatives as necessary.
• Represent MS&T on VPT and project teams. Works closely with Supply Relationship Manager and project team members in developing strategies and problem-solving efforts.
• Where appropriate, engage with brand teams and ExM business units to raise awareness and manage/mitigate risks to product supply, supporting the identification of continuous improvement and business continuity projects.
• Product robustness -
• Technical lead/ product owner for creation of robustness monitoring plan, control strategy
• provides technical oversight to ensure continuous process monitoring for all products within scope.
• Communicating output of product performance reviews with VPT and others groups as required
• Identifying and executing robustness improvement projects, where required

Qualifications, Knowledge and Skills Required:

• Must have in-depth knowledge of bulk drug product - recognized as a technical leader and subject matter expert Oral Solid Dosage (OSD), Semi-solids, Liquids, Sterile/Aseptic products manufacturing.
• Experienced with use of statistical software to analyze process related data to determine process capability or for troubleshooting purposes.
• Proficient in the technical transfer of products to CMOs within budget and according to project timeline. Demonstrated ability to project manage one or more tech transfer projects with minimal supervision.
• Substantial experience of manufacturing support activities (change control, investigations, process optimisation)
• Excellent verbal, written communications and presentations skills, including excellence at writing complex study plans and scientific reports; informed line management about the critical issues related to product manufacturing and process / package validation where appropriate.
• In depth understanding of regulations concerning cGMP, manufacturing/packaging/artwork, validation, quality systems, equipment innovations, upgrades, and instrumentation.
• Ability to work on own and as part of a team and to drive issues to resolution.
• A degree in science or a related field with a minimum of 7 years relevant experience.
• Proven record in pharmaceutical technology, technology transfer, process development and manufacturing support/activities.
• Experience of statistical software.
• Demonstrable experience of analytical method validation.
• Ability to interact at all levels of the organisation with proven influencing ability e.g. Regulatory, Supply Chain, CMO, etc. to achieve goals.
• Ability to understand business implications of technical decisions.

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance.