7 days old

Sr. Manager, MS&T

Rockville, MD 20850
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We go where others wont, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world.Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

I: Job Summary
The Technical Transfer Manager is responsible for ensuring leadership of technical transfer of product/process manufacturing from one site to another and to/from Customers and/or potential 3rd parties. The incumbent is aslo responsible for technology transfer activities at site level, including any scale-up, cost-reduction goals and product line efficiency of the product life cycle.

The complexity of the work demands strong technical background across a variety of scientific disciplines and fundamentals on technical transfer which includes manufacturing process technologies and biopharmaceutical best practices. The incumbent work closely with technical/management representatives from other Emergent sites, Customers, as well as cross functional teams on the Rockville site. This individual has critical interaction with the Project Management and Business Development team.
II: Responsibilites

Business

Maintain good working relationships with internal and external partners/customers with MS&T (Project Management, Business Development, QC, QA, Eng, Mfg, etc.)
Responsible for working with applicable Project Managers to ensure departmental resources are appropriately allocated based on work scope and technical needs.
Track and report status on KPIs relevant to Technical Transfer activities/responsibilities and ensure commitment to key stakeholders are met in a timely and quality manner.

Technical

Manage technical aspects of technical transfer from the process perspective for products from one manufacturing site to another, third parties or Customer to site, including for example:
o Supports the project team with respect to scaling up processes, new equipment and procedures, equipment and process validation, and manufacturing of development, stability, and process qualification batches.
o Manage the research of new manufacturing technologies to further fine-tune technology transfer activities and overall process improvement
o Initiate change control in system and ensure approval and closure
o Coordinate Trial, Engineering, Clinical and Regulatory Batches according to defined protocol
o Write Manufacturing Process Transfer Plan/Report including check list for equipment, process, materials, components, among others.
o Ensure that key procedures (e.g., process , sterilization) are properly established (including initiation of EHS reviews udits /requirements where necessary)
o Author experimental design, tech transfer reports, and development reports.
o Author manufacturing batch records and SOPs for new processes and equipment.
Product transfer (scale-up)
o Support Business Dev and Project Management for transfer to commercial site
o Technical assessment for in-licensing products (i.e., due diligence)
o Involvement of MS&T experts in Technical Project Teams during development phases for manufacturing feasibility assessment
Lead optimization of manufacturing operations to reduce internal and client costs
o Assesses manufacturing processes by risk analysis method(s) and uses results to design robust manufacturing processes.
o Research and implement new methods and technologies to enhance operations.
o Prepares master batch records and protocols for the manufacture of development, stability, and process performance qualification batches. Translates development findings into manufacturing processes.
o Provides technical assessment of changes in manufacturing through appropriate review of documentation and testing results

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

III: Education, Experience & Skills

Minimum of a Bachelor of Science in Biology, Chemistry, Chemical Engineering, Biochemistry, or related life science
8+ years of experience in pharmaceutical or biopharmaceutical manufacturing with strong knowledge on GMP/cGMP and FDA regulations in the Pharmaceutical Industry.
Detail oriented with strong written and verbal communication skills. Requires proficient presentation and technical writing abilities
Diverse and demonstrated technical knowledge with strong risk management mindset
Ability to work independently, within prescribed guidelines, or as a team member
Ability to travel domestically and internationally as needed
Computer skills (MS Office, MS Word/Excel, Visio, MS Project)

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy<> .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Lead with Integrity
    • We gain trust and confidence through ethics, quality, and compliance excellence
  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.

Industry

  • Biotechnology
Posted: 2023-01-25 Expires: 2023-02-25

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Sr. Manager, MS&T

Emergent BioSolutions Inc.
Rockville, MD 20850
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