Job Information
Bristol Myers Squibb Scientist - Parenteral External Manufacturing MS&T in New Brunswick, New Jersey
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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.
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The Scientist provides technical support to the External Manufacturing Organization (ExM) for manufacturing of commercial drug products at Contract Manufacturing Organizations (CMO's) as an individual contributor. The individual will act as single point of contact for technical matters for a particular brand/line at the CMO, and will perform Person in Plant duties (PIP) in support of technical transfer and commercial manufacturing activities. The scientist will also ensure the transfer of robust manufacturing processes to CMO from Bristol Myers Squibb (BMS) Product Development (PD)/ Global Product Development and Supply (GPS) or CMO. The scientist will also ensure robust process performance at CMO during commercial manufacture by use of continuous process verification, Operational Excellence (OPEX) principles, etc. to reduce supply risks.
Key Responsibilities:
Making multiple trips to manufacturing site for getting hands-on training on DP manufacturing process (30% travel for first 6 months, 15% travel after 6 months).
Supporting CMO/vendor selection with Procurement, Quality, and other business functions: preparation of technical information packages, participation in due diligence and site assessments, technical evaluation of requests for information (RFIs) and requests for proposal (RFPs).
Technical single point of contact and BMS Site Implementation Lead to contract manufacturing organizations in support of technical transfers. This includes review and approval of site technology documents such as Engineering Studies, characterization Protocols, Validation Protocols, Process Risk assessments, etc. This likely will include Person in Plant (PIP) support.
Execution of Process Owner Role at a single contract manufacturing site for a single product and line. This includes process capability analysis and Continuous Process Verification of key quality attributes and parameters at the CMO, identifying and executing process robustness improvement projects where required. Use of this knowledge to ensure timely, comprehensive and accurate process data reviews, to support generation of Annual Product Quality.
Review documents for commercial products and to ensure compliance and security of supply - metrics review, investigation close-out, change control review, annual reviews and continuous improvement.
Provide technical guidance in the understanding of root cause analysis, impact assessment and corrective and preventive action (CAPA) identification for out of trend or out of specification results or deviations for DP manufacturing.
Technical input, and/or authoring, of CMC documents, support CMC query resolution with Global Health Authorities, and support of plant inspections.
Participation on various matrixed teams to drive technical process improvement strategies.
Driving the use of strategies, resources and processes (OPEX etc.) to improve processing efficiency and to ensure optimized technical support for manufacturing, technical transfer and scale-up of processes to commercial scale.
Support operational management of CMO as per Virtual Plant Team (VPT) governance structure.
Represent Manufacturing Science and Technology on project teams and works closely with Quality Assurance (QA), Global Procurement, Supply Chain, Supply Relationship Manager (SRM), Product Development (PD) and project team members in developing strategies and problem-solving efforts.
Assists and/or leads moderately complex technical projects and life cycle project activities at CMOs.
Assists and/or leads and coordinates change requests and process deviations.
Collect, maintain data for process robustness analysis to support life cycle activities at CMO’s.
Desired Skills/Experience:
Thorough understanding in sterile manufacturing processes, with a strong knowledge of global regulatory requirements (e.g. FDA) related to the design and control of these processes.
Understanding of engineering, analytical and regulatory (current Good Manufacturing Practices (cGMP), filing, Environmental Health and Safety (EHS)) aspects of drug product (DP) manufacturing.
Demonstrates ability in strategic and analytical thinking, problem solving and rapid decision-making skills.
Experience of managing CMO relationships.
Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous environment.
Demonstrated ability in negotiating and influencing without authority in complex, high impact situations.
Knowledge of SOPs, cGMPs and GLPs and the know how to work and manage within a regulatory environment.
Generally proficient technical writing skills, as well as the ability to translate technical issues into business impact and relevant solutions.
Ability to work within and lead cross-functional technical teams, across multiple cultures.
Demonstrated capability to design, author, and execute process development, qualification, and validation protocols (e.g. PPQ) consistent with current Global Health Authority requirements.
Understanding of statistical process analysis, including use of statistical software platforms (e.g. Minitab, J M P) to determine trends and variability across inter-batch data sets. Familiarity with Design of Experiments, Quality by Design, and Risk Assessment concepts commonly employed in pharmaceutical process development.
Demonstrated ability to: 1) influence areas not under direct control to achieve objectives 2) work strategically, manage multiple programs consistent with department objectives 3) build alignment with business partners including Procurement, Quality, and CMO stakeholders and 4) manage risk and make rapid decisions.
Demonstrated project management experience.
Demonstrated experience with the execution of Technology Transfer and scale up programs for commercial manufacturing processes of parenterals.
Experience with formal risk assessment and investigational tools such as pFMEA, Ishikawa Fish Bone.
Experience/understanding different Automation software programming is a plus.
Process development experience on nanoparticle based formulation is a plus.
Required Qualifications:
Bachelor's degree in relevant engineering or science discipline (chemical/mechanical /bioprocess engineering, biochemistry, pharmacy, microbiology or a related pharmaceutical science) is required.
Masters or PhD level degree is strongly preferred.
Minimum of 4-5 years of experience as a BS degree, 1-2 years of experience as a MS degree and 0-1 years of experience as a PhD is required.
Required Travel:
International travel is required.
30% travel to CMO site for first 6 months, 15% travel after 6 months.
#LI-ONSITE
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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Company: Bristol-Myers Squibb
Req Number: R1580262
Updated: 2024-04-30 01:45:15.604 UTC
Location: New Brunswick-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.