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Scientific Associate Director, Microbiology

3 months ago

New Brunswick, United States BioSpace, Inc. Full time
Job Details

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 .

Our Analytical Strategy and Operations team creates transformative medicines of tomorrow based on the cutting-edge science of today. Working within Global Product Development and Supply this team uses state-of-the art technologies to develop, enable and execute analytical and CMC strategies that ensure safety, quality and efficacy of life-saving medicines administered to patients in clinical studies. Our team is involved at the earliest stages of Pharmaceutical and Biopharmaceutical product development through the successful commercial launch. As a member of our team, you will get the chance to play a pivotal role to positively impact patients' lives while developing professionally to achieve your own career goals.

Job Title: Scientific Associate Director

Location: New Brunswick

Division: Global Production & Supply/Pharmaceutical Development/Analytical Strategy & Operations

Position Summary

This position will support the harmonization of microbiological testing for the Clinical Supply organization in New Brunswick, as well as the BMS network of microbiologists, in support of global Environmental, Sustainability and Governance (ESG) goals. Supported methods will include all aspects of aseptic drug product processing, including small molecules, biologics and cell therapy. The position also provides compliance information for inspection readiness at all microbiological testing locations in the BMS network. The Scientific Associate Director will also ensure appropriate strategies for DP-related manufacturing activities and will write or review microbiological sections of regulatory filings in compliance with current global expectations. This position is a combination of office based and laboratory-based work, and includes data analysis and experimental design, as well as network microbiological support for new and existing products within BMS.

Direct Reports & Indirect Reports Business Partners

This position will not have formal direct reports. Position will be supported by Assistant and Associate Research Scientists within the Microbiology Center of Excellence as indirect reports. Business partners are BMS site-based QC Microbiology Laboratories, Manufacturing Science & Technology/Process Microbiology and Manufacturing Science & Technology /Parenterals.

Role & Responsibilities:
  • Functions as subject matter expert for microbiological assays and aseptic manufacturing supporting the BMS organization.
  • Provide specific strategic microbiology support to alternative methods in support of company ESG goals.
  • Participation in site assessments/vendor selection for CMOs/vendor with Procurement, MS&T, Quality, and other business functions. May act as SME on Quality audit team for External manufacturing sites.
  • Involved in troubleshooting issues and ensures that testing performed by external contract laboratories is technically sound and in compliance with BMS corporate, regulatory, quality and compliance expectations and requirements.
  • Ensures inspection readiness of the Microbiology Operations laboratory in New Brunswick and globally for QC microbiology laboratories in the network.
  • Supports the investigation and implementation of new technologies and methods for microbiological assays.
  • Support complex investigations involving microbiological assays or issues, including generation of CAPAs and change controls.
  • Provides support for the preparation, review and approval of microbiological methods and validation sections of regulatory filings, as well as responses to regulatory agency questions regarding sterile drug products produced by aseptic processing.
  • Provides dedicated support and access to expertise for customers within the Manufacturing Science & Technology Parenteral manufacturing department, by regular communication with department members.
  • Participate in internal and external industry forums to understand evolving regulatory expectations and industry best practices.
  • Travel to other sites or educational conferences will be required (20%).
Experience & Qualifications:
  • Ph.D. with 8-12 years of experience or MS with 12-15 years of experience or BS with 15+ years experience with degree in Microbiology, Molecular Biology, Virology, or Biology/Biological Sciences.
  • Advanced experience in pharmaceutical microbiology
  • Advanced knowledge of regulations for pharmaceutical and biopharmaceutical drugs, including specific review or preparation of INDs, BLAs, NDAs, ANDAs or supplements.
  • Motivated, adaptable, and results oriented professional
  • Capable of mentoring junior staff
  • Experience in the inspection process for US and international Heath Authorities.
  • Experience in aseptic manufacturing plant(s) with regulatory interaction regarding sterilization practices and aseptic technique.
  • Ability to build strong, trusting relationships, and work across divisions, diverse business backgrounds and cultures.
  • Excellent communication and interpersonal skills with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
  • Involved in pharmaceutical industry professional groups and forums
  • Experience with working in a matrix environment. Experience interacting with senior leaders and being an influencer/negotiator
Ideal Candidates Would Also Have:
  • Direct experience in Board of Health audits for biologic or pharmaceutical production
  • Direct experience with writing CMC Drug Product sections of regulatory filings
  • Experience in a network role across multiple sites in a pharmaceutical company
Working Conditions:

Work is performed in a cGMP compliant laboratory following techniques which require one to maintain a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials. Work may be required on weekdays, weekends, holidays, and during adverse weather conditions. Flexibility to work irregular hours on short notice.

Development Value:

This is a technical level position, enabling the incumbent to deepen their laboratory skills, influence the network, and gain exposure to leadership within an innovative biopharmaceutical company. The position resides in the Pharmaceutical Development organization, in the Analytical Strategy & Operations division, Microbiology Center of Excellence department. The Microbiology Center of Excellence owns the microbiology assays for the company globally, and uses deep scientific microbiology knowledge to solve issues, drive harmonization, and initiate innovation across the various site QC microbiology laboratories.

Why You Should Apply

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

#LI-Hybrid

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/ 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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.