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 support process validation activities as a member of the Technical Transfer Process (TTP) Team which is a part of the Manufacturing Science & Technology (MS&T) Department. The candidate will primarily be responsible for supporting multiple technical transfer projects. Responsibilities include designing experiments/studies, authoring protocols (e.g., engineering runs; process performance qualifications), reviewing complex data, and authoring process validation reports. Previous expertise with fill/finish operations, process validation, and technical writing are critical to this role. Candidate must also have excellent communication skills, both written and verbal.
Key Duties will include:
Act as key technical lead for process development. Independently design and manage studies for process development, process optimization, scale-up, and technology transfer.
Independently design studies for evaluating the robustness of the process. These studies will serve as a baseline for the 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.
Works with client’s lead technical staff 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 pricing of the project and assist in preparation of project proposals.
Function as the SME for Manufacturing processes and Technical Transfer of new products in regard to process development.
Collaborate with analytical, production, quality and project management team and ensure timely completion of project deliverables.
Independently review and analyze complex process data from the commercial manufacturing batches for conformity and facilitate batch release.
Works independently and provide guidance to lower level personnel or as a team member. Execute QbD 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 biennially or as part of process improvements.
Apply CGMP and CGDP to all areas of work.
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
B.S. in Science or Engineering with a minimum of 7 years of equivalent 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 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
Experience and knowledge of sterile processing.
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.
Proficient knowledge of CGMP.
Coordinate multiple tasks simultaneously.
Regulatory background in pharmaceutical development/research is a plus.
IV: Physical/Mental Requirements
Type/keyboard, stand, walk, sit. Use phone, fax, copier, and computer. Organize/coordinate, analyze/interpret, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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.