Senior Principal Scientist driving nonclinical safety strategies for Degrader - Antibody Conjugate programs at Orum Therapeutics. Overseeing nonclinical toxicology studies and collaborating with cross - functional teams.
About the role
- Principal Scientist providing technical support for Drug Product Development at Bristol Myers Squibb. Leading technology transfer and maintaining process performance at contract manufacturing organizations.
Responsibilities
- Provide technical support to the External Manufacturing Organization and (ExM) Contract Manufacturing Organizations (CMOs) as a team leader or individual contributor.
- Provide technical support as Drug Product Development to Launch representative to the BMS Internal Manufacturing Organization as a team leader or individual contributor.
- Ensure the transfer of robust manufacturing processes to internal site and/ or CMO from Bristol Myers Squibb (BMS) Product Development (PD)/ Global Product Development and Supply (GPS) or CMO.
- Ensure robust process performance at CMO during commercial manufacture by using continuous process verification, Operational Excellence (OPEX), etc. to reduce supply risks.
- Maintain current knowledge of technology to support successful operation of the ExM business unit.
- Support CMO/vendor selection process and/or internal site selection – 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 organizations.
- 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 Providing technical oversight to ensure continuous process monitoring for all products within scope. Communicating output of product performance reviews with VPT and other groups as required Identifying and executing robustness improvement projects, where required.
- Support finance with compilation of budget.
- Supervise work of MS&T Manager / Scientist as required.
Requirements
- 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, process validation, and manufacturing support/activities.
- Experience of statistical software.
- Ability to interact at all levels of the organization with proven influencing ability e.g. Regulatory, Supply Chain, CMO, etc. to achieve goals.
- Ability to understand business implications of technical decisions.
Benefits
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: T he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
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