Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
I. JOB SUMMARY
The candidate will lead process validation activities and manufacturing process transfer as a member of the Technical Transfer Process Team which is a part of the Manufacturing Science & Technology (MS&T) Department supporting the contract manufacturing business unit. The candidate will primarily be responsible for leading one or more technical transfer projects for the aseptic fill and finish of pharmaceutical and biological drug products. Responsibilities include leading project teams, designing experiments/studies, authoring protocols (e.g., engineering runs; process performance qualifications), reviewing and analyzing complex data, and authoring process validation protocols and reports. Candidate will support the development of manufacturing production records and coordinate process specific training with manufacturing and laboratory personnel.
Previous expertise with contract manufacturing, technology transfer, fill/finish operations, aseptic and/or isolator manufacturing, process validation/process performance qualifications, and technical writing are critical to this role. Candidate must also have excellent communication skills, both written and verbal.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Lead one or more technology transfer project teams including, but not limited to:
- Conduct, plan, and lead technology transfer of manufacturing processes.
- Coordinate technical activity associated with assigned projects (e.g. completion of new equipment validation, material procurement and implementation, etc.).
- Collaborate with analytical, production, quality and project management team and ensure timely completion of project deliverables.
- Evaluate incoming processes for operability and lead process and facility risk assessment activities.
- Work with project management and external groups to support technology transfer activities.
- Author and review technology transfer and manufacturing documents including plans and reports.
- Act as key technical lead for process development. Independently design and manage studies for process development, process optimization, scale-up, manufacturing records and technology transfer.
- Independently design studies for evaluating the robustness of the manufacturing process. These studies will serve as a baseline for the further process validation activities.
- Independently evaluate process data and perform in-depth analysis using scientific principles for evaluation of critical process parameters governing the performance of the process. Exercises judgement in selecting methods, techniques and evaluation criteria.
- Represents MS&T department as subject matter expert routinely in meetings/conference calls with clients
- Works with client’s lead technical staff, department management and senior management to evaluate complex technical details pertaining to the project and defines the scope of the project.
- Makes recommendations to the business development team regarding project studies and assist in preparation of project proposals.
- Function as the Subject Matter Expert (SME) for Manufacturing processes and Technical Transfer of new products regarding process development.
- Independently review and analyze complex process data from the clinical and commercial manufacturing batches for conformity and facilitate batch release.
- Works independently and provide guidance to lower-level personnel or as a team member.
- Execute Quality by Design experiments to support the development and characterization of new manufacturing processes.
- Independently manage multiple cross-functional projects that may require regulatory submissions.
- Effectively present complex technical information to guide decision making.
- Independently author technical documents such as protocols, reports, deviations, gap analyses, risk assessments, etc.
- Provide technical support for fill finish manufacturing activities including OOS/OOT investigation, process deviation impact, root cause investigation, process change and optimization.
- Perform periodic review of processes/systems.
- Write and revise SOPs and Master Plans, as necessary.
- Apply CGMP and CGDP to all areas of work.
- Provide training to production/laboratory staff for protocol requirements and new manufacturing processes.
- Work with individuals at all education/experience levels and with multiple departments (production, laboratory, engineering, materials management, etc.)
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
- B.S. in Science or Engineering discipline with a minimum of 8 years of related job experience. M.S. in Science or Engineering discipline with a minimum of 5 years of related job experience. PhD in Science or Engineering discipline with a minimum of 3 years of related job experience.
- Strong leadership skills; high level of personal/departmental accountability and responsibility.
- Strong understanding of process design principles.
- Experience with drug product manufacturing processes transfer, development, process scale-up and optimization.
- Ability to perform well under tight timelines and excellent decision-making quality under pressure is desired.
- Ability to manage multiple priorities and tasks in a dynamic environment.
- Excellent written and communication skills.
- Data evaluation and interpretation, including statistics and process controls.
- Experience and knowledge of sterile processing principles (aseptic or isolator technology).
- Training and experience working in a BSL-2 facility is a plus.
- Ability to exercise judgment to determine appropriate corrective actions.
- Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.
- Ability to work in a team environment with multiple departments and experience/educational levels.
- Proficient knowledge of CGMP.
- Regulatory background in pharmaceutical development/research is a plus.
Requires vaccination against different viruses including Vaccinia virus.
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.