- Emergent BioSolutions
- Rockville, MD
- Start date
- Mar 25, 2023
- Engineering, Chemical Engineer, Science/R&D, Biology, Chemistry
- Required Education
- Bachelors Degree
- Position Type
- Full time
We go where others won’t, 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 also 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. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- 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.
- 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:
- 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.
- Manage the research of new manufacturing technologies to further fine-tune technology transfer activities and overall process improvement.
- Initiate change control in system and ensure approval and closure defined protocol.
- Write Manufacturing Process Transfer Plan/Report including check list for equipment, process, materials, components, among others.
- Ensure that key procedures (e.g., process, sterilization) are properly established (including initiation of EHS reviews /audits /requirements where necessary)
- Author experimental design, tech transfer reports, and development reports.
- Author manufacturing batch records and SOPs for new processes and equipment.
- Product transfer (scale-up):
- Support Business Dev and Project Management for transfer to commercial site.
- Technical assessment for in-licensing products (i.e., due diligence).
- 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.
- Assesses manufacturing processes by risk analysis method(s) and uses results to design robust manufacturing processes.
- Research and implement new methods and technologies to enhance operations.
- Prepares master batch records and protocols for the manufacture of development, stability, and process performance qualification batches. Translates development findings into manufacturing processes.
- Provides technical assessment of changes in manufacturing through appropriate review of documentation and testing results.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
- Minimum of a Bachelor of Science in Biology, Chemistry, Chemical Engineering, Biochemistry, or related life science
- 2-3 years of managerial experience or 5+ 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.
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.
Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter.
Stock Symbol: EBS
400 Professional Drive
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