Scientist, Analytical Chemistry Tech Transfer

Location
Baltimore (Camden), MD, US
Posted
Mar 18, 2021
Ref
724259500
Hotbed
BioCapital
Required Education
Other
Position Type
Full time
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

Individual working at this position will lead the analytical testing activities related to drug product manufacturing and will possess advanced knowledge of Analytical Chemistry or related field. His/her duties will span method validation, method transfer, compendial assessments, method optimization (some method development), investigating method robustness, troubleshooting the root cause of erroneous results related to methods and developmental manufacturing studies. Individual will manage the projects and work closely with other MS&T members, management, project managers, clients and network with scientists in his field both internally and externally to improve the technical expertise of the new method or process at Camden site of Emergent. This position demands independently designing studies that lays the foundation for the analysis of samples that will support manufacturing, hence solid understanding of scientific principles related to analytical methodologies and instrumentation is required.

II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Act as key technical lead for new and existing method evaluation. Independently design and manage studies for method validation, method transfer, compendial method assessments, and optimization (with some method development), supporting technology transfer.
• Independently write protocols, reports, etc. that support the execution of the above activities. These studies will serve as a baseline use of validated methods in the QC laboratory, supporting process validation activities.
• Independently evaluate analytical 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 management to evaluate details pertaining to the project and defines the scope of the project.
• Works with management and make recommendations for investment in new technology regarding analytical laboratory improvements.
• Function as the analytical SME supporting manufacturing processes and technical transfer of new products regarding process development.
• Collaborate with MS&T, production, quality and project management team and ensure timely completion of project deliverables.
• Independently review and analyze testing data from the manufacturing batches for conformity and that will eventually help facilitate batch release.
• Work independently and provide guidance to lower level personnel or QC laboratory analysts.
• Execute feasibility experiments to support the new method qualifications.
• Independently manage multiple cross-functional projects.
• Effectively present 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, analytical deviation impact, root cause investigation, method changes and optimization.
• 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 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
• BS in Chemistry or related scientific field with a minimum of 5 years of equivalent job experience. MS in Chemistry or related scientific field with a minimum of 3 years of equivalent job experience.
• Strong leadership skills; high level of personal/departmental accountability and responsibility.
• Strong understanding of analytical testing methodologies, chromatographic and spectrophotometric techniques.
• Experience using HPLC, UPLC, GC, UV, ELISA, SDS-PAGE, Karl Fischer, Electrophoresis, etc., utilizing excellent analytical skills and techniques.
• Experience with Empower software.
• Experience with method optimization or development, and method validation.
• Experience and knowledge of compendial procedures (USP, EP, JP).
• Experience in technical writing (protocols, reports, deviations)
• Good understanding and experience in handling, small molecule and biopharmaceutical protein-based drug products (peptides, DNA, mAbs) is desired.
• Excellent computational skills and background in Microsoft Excel.
• Ability to perform well under tight timelines and excellent quality decision making under pressure is desired.
• Ability to manage multiple priorities and tasks in a dynamic environment.
• Excellent written and communication skills.
• Ability to exercise judgment to determine appropriate corrective actions.
• Ability to exercise judgment for defined practices and policies in designing and executing method validations.
• Ability to work in a team environment.
• Proficient knowledge of CGMP.
• Coordinate multiple tasks simultaneously.
• Regulatory background in pharmaceutical method development/research is a plus.

IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

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.

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