Senior Scientist, Drug Product Development
- Emergent BioSolutions
- Gaithersburg, MD
- Start date
- Mar 12, 2023
- Marketing, Science/R&D, Biotechnology, Pharmacology
- Required Education
- Masters Degree/MBA
- 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.
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
Develop formulations for liquid, frozen and lyophilized drug products to ensure superior stability and manufacturing feasibility. Develop characterization methods for in-process, bulk drug product, and final drug product samples to establish product and process knowledge. Determine leading formulations for clinical trials and support technology transfer of formulation processes to GMP manufacturing sites.
Prepare CMC sections related to formulation and analytical development. Provide scientific guidance, input and ideas to solve complex problems.
Serve as technical lead for internal development and external client projects, managing interface with external clients / sponsors as well as internal Emergent functions such as analytical development, quality, upstream and downstream drug substance operations, and CMO manufacturing sites. Ensure work is completed within schedule and budget and in compliance with Regulatory/Quality standards.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Provide leadership within internal development and external client projects on technical, budgetary, and operational areas.
• Identify formulations and formulation processes that ensure the stability of biologic drug products.
• Plan, perform and execute short and long-term stability and compatibility studies and experiments to support internal development projects, external client projects, animal toxicity studies, CTM phase I/II/III studies and more.
• Lead development of appropriate physicochemical characterization assays in-process, bulk drug product, and final drug product samples
• Determine primary degradation pathways for components of biologic drug products, including protein, oligonucleotide, lipid, adjuvant, and others.
• Support Technology Transfer to manufacturing sites by 1) completing process characterization for determination of critical process steps and parameters 2) defining operating ranges 3) completing technical transfer reports 4) supporting process start-up at commercial scale and 5) reviewing manufacturing batch record.
• Review, analyze, and interpret data from experiments.
• Prepare technical reports, project monthly reports, PowerPoint presentations and other documentation reflecting project(s) progress, highlight delays or potential risks to project timelines.
• Present project updates to immediate supervisor, team members, external clients / sponsors, and upper management on regular basis.
• Utilize broad knowledge and application of the scientific theories and principles to solve problems related to formulation and formulation process development.
• Write SOPs, protocol, monographs, and technical reports; seek approval from management and R&D QA.
• Satisfactorily completes all development, cGMP/GLP and safety training in conformance with Departmental requirements.
• Where applicable, performs job responsibilities in compliance with cGMP/GLP and all other regulatory agency requirements.
• Performs other duties as assigned.
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
Education: PhD with minimum of 3 years of scientific pharmaceutical industry experience or MS degree with minimum of 10 years of industry experience.
Experience: Laboratory experience in developing formulations for vaccine and biologics for sterile parenteral administration in both pre-clinical and clinical studies required; Lyophilization experience highly preferred. Experience with technology transfer to GMP manufacturing site.
Knowledge: Expert knowledge of scientific principles and concepts related to biologic drug product and vaccine development. Chemistry, biochemistry, DoE and JMP analysis, regulations and guidelines in pharmaceutical industry (FDA, USP, EU, others). Understanding of appropriate stability indicating techniques for evaluation of drug products. In-depth hands-on knowledge of the formulation/fill/finish processes for biologic products, aseptic formulation and processing technologies, and application of lyophilization technology.
Knowledge in GLP or cGMP is preferred.
Skills: Excellent communication, writing, and collaboration skills. Ability to work to tight deadlines and adapt to changing priorities in a fast-paced team environment. Self-motivated, organized, and able to independently solve complex technical problems.
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
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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