Bristol-Myers Squibb Company

Associate Scientist

Location
Devens, MA, United States
Posted
Sep 14, 2019
Ref
R1517799
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Associate Scientist - Stability

Description - External

Global Biologics Stability (GBS) manages the stability programs for all commercial biologic Drug Substance and Drug Products across all internal and external manufacturing sites. The Associate Scientist reports to the Associate Director of GBS and is responsible for coordinating and performing all new study enrollment activities. Activities include planning, scheduling, and tracking all yearly stability enrollment requirements, coordination with internal and external manufacturing sites to obtain samples, maintaining GMP documents for commercial biologics stability studies, and authoring a year-end reconciliation document. The Associate Scientist may also assist with stability protocols, assessment and strategy, sample management, data evaluation and trending, and data reporting in accordance with cGMP and Company SOPs.

MAJOR DUTIES AND RESPONSIBILITIES:

- Oversight to all stability enrollment activities for approximately 150 new stability studies per year

- Author and maintain stability requirement documents (stability annual requirements, year-end reconciliation)

- Clear and frequent tracking, communication of the enrollment plan with internal and external manufacturing sites and within GBS.

- In collaboration with all internal and external biologics manufacturing sites, select the batches required to fulfill the stability annual requirements.

- Enrollment Forms: initiate the GMP forms, ensure completion, review and approval by all contributing functions.

- Lead the planning and scheduling for SM LIMS study builds and incoming stability sample shipments

- Participate and/or lead OpEx initiatives to streamline and standardize the stability study enrollment process.

- Identify, Write and revise SOPs for managerial review and approval.

- Escalate information regarding stability program that may impact lab capacity, product studies or regulatory commitments directly and promptly to management.

- Works according to cGMP requirements and HA expectations.

Qualifications - External

KNOWLEDGE AND SKILL

- Minimum of 4 years (MS)/ 6 years (BS) relevant experience (biopharm or related Laboratory) at an Associate Scientist 1 Level (at BMS or other company). Knowledge of science generally attained through studies resulting in a BS/MS Degree or equiv. preferably in Biological Sciences.

- Proficiency in at least one discipline (cell based Bioassay, Immunoassay, Separation technology [chromatography], Bioburden and Endotoxin, Stability, trending, Investigations); technical knowledge/SME in a technical discipline.

- A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to quality control laboratories in a biologics manufacturing facility.

- Excellent organization and communication skills

- Ability to work independently and collaboratively in a team matrix environment is required; promoting a high commitment to business goals and objectives.

-Proficient in software applications such as LIMS, SAP, Trackwise, and Microsoft Office applications.

- Knowledge of US/EU stability requirements and industry best practices is preferred

- Develops strategies for solving complex problems/issues with coaching.

DECISION MAKING

- Associate Scientist may work on assignments that are extremely complex in nature where independent action and a high degree if initiative are required in resolving problems and developing recommendations.

SUPERVISION RECEIVED

- Associate Scientist work independently and assist with the creation of detailed instructions on new assignments.

SUPERVISION EXERCISED

- May have direct supervision duties. Associate QC Scientist will participate in training less experienced staff in normal operational tasks.

Level

- D04

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.