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.
The Manager for Analytical Development, Bio/Biochem will be responsible for providing leadership, management, and oversight to Analytical Development Bio/Biochem functions, testing, method development, method technology transfer and method validation activities. This position will also ensure testing deliverables are completed in a timely and efficient manner.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Oversees and manages the activities involved with the development and transfer of test methods.
- Directs and performs assay development, technology transfer, validation and routine testing for biopharmaceutical products, utilizing biochemical and cell-based assay formats.
- Responsible for design, development, execution and statistical analysis of validation protocols for analytical, bioanalytical, and compendial methods used for the analysis of products and process impurities.
- Provides technical expertise for method optimization, verification, qualification and validation. This includes analyzing and interpreting data, writing protocols and reports, investigating analytical problems and developing approaches to rectify those problems.
- Collaborate closely with Quality Assurance to ensure compliance with corporate and departmental quality guidance.
- Interacts with contract, corporate, and governmental agency representatives and auditors. Collaborate with senior management to assist with setting and modifying goals, budget and operations related to the functional area.
- Preparation and oversight of methods, protocols, trend reports and summaries as required and for ongoing programs and tech transfer activities.
- Perform occasional technical presentations to senior management; participate in departmental staff meetings.
- Review current laboratory practices to identify alternative strategies or cost saving measures for laboratory improvement.
- Prepares and provides scientific review and approval of protocols, reports, study designs and standard operating procedures.
- Performs managerial duties in support of Analytical Development operations such as resource management and fulfillment of project deliverables.
- Investigate, troubleshoot, and resolve test method and equipment deviations and CAPA's, as well as provide SME support as needed.
- Demonstrates strong organizational and technical writing skills.
Other responsibilities include but are not limited to:
- Assist with resourcing and cost analysis for preparation of client proposals
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.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
- Bachelor's degree in Microbiology, Biochemistry, or closely related scientific discipline with at least 8 years of relevant experience or MS with a minimum of 5 years of relevant experience.
- Must possess skills and knowledge of general immunological, bioanalytical and chemical test methods such as ELISA, qPCR, IEF, TCID50, Plaque Assay, SDS-PAGE, Western Blot, Microbiological methods, Endotoxin testing, CE, and UV spectroscopy.
- At least 3 years prior supervisory experience required.
- Advanced knowledge of cGMPs, safety and data integrity.
- Experience in executing phase appropriate method qualifications and validations.
- Experience in assay method validation, technology transfer, equipment validation, and analytical investigation for biotherapeutic and vaccine products.
- Ability to apply statistical analysis to data analysis and trending.
- Ability to partner and influence across a matrixed environment
- Excellent communication skills; verbal and written
- Able to work in a fast-paced environment and adapt based on business needs
- Must be a team player and be able to mentor and develop others•
PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.
The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
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.