Process Development Senior Specialist - Bio-analytics focus
Merck & Co.
Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
At our campus in Elkton, Virginia, we currently have an opening for a Senior Specialist in our Biologics Process Development group. The manufacturing facility is located in the Shenandoah Valley along the Shenandoah River and the Blue Ridge Mountains a short distance from the University of Virginia and James Madison University.
A successful candidate will have the opportunity to apply their enthusiasm and technical skills as a member of a multidisciplinary team supporting the operation of pharmaceutical, biopharmaceutical, vaccine product manufacturing facilities. This position provides a unique opportunity to contribute at an individual level and also to supervise and mentor a team. More specifically, the Process Development Senior Specialist will participate in driving the development, optimization and characterization of current and future fermentation and purification processes at the laboratory and pilot scales by leading downstream process development operations.
The candidate should have strong experience with biochemical laboratory tools and techniques used for purification of recombinant proteins, process optimization and analytical methods. (i.e., chromatography, tangential flow filtration (TFF), analytical HPLC, electrophoresis, ELISA etc.) The ability to learn quickly and work in a fast-paced team environment is desirable. Additional responsibilities include good documentation practices and maintaining an electronic laboratory notebook and adhering to strong safety culture.
Experience and Qualifications
- Recombinant protein purification and protein analytical methods
- Effective problem-solving skills and a hands-on approach to problem solving, with a bias toward going to see problems for oneself in the field
- Ability to work independently and within a team collaborating with multiple partner teams
- Reliable attention to detail
- Reliable and effective technical, organizational, interpersonal, collaborative, and verbal/written communication skills
- Enthusiasm, confidence and initiative-taking ability needed for continuous learning and its applications
- Strategic ambition to succeed and to help others to do the same
- Ability and willingness to supervise a team of laboratory scientists with varying levels of experience
- Process development in a laboratory and pilot setting
- Bio-analytical methods for proteins and nucleic acids including but not limited to electrophoresis, ELISA, PCR, RT-PCR, CIEF, flow cytometry etc.
- HPLC, microfiltration systems for recombinant protein purification
- Planning and coordinating laboratory operations
- Waters/Empower platform for both HPLC and UPLC
- GLP/GMP environment is a plus
- Flexible work schedule – occasional shift work
- Design of Experiments (DOE), statistical data analysis and presentation of results/conclusions
- Efficient and effective organization skills to manage multiple projects or assignments
- Troubleshooting technical issues (experimental, instrument-related issues etc.)
- Method development and method transfer.
- Effective written and verbal communication skills
- Participation in regulatory agency inspections
- Strong preference to safety culture
- Mentoring and supervising colleague team members in laboratory and scientific procedures
Education Minimum Requirement
- Bachelor of Science degree in biochemistry | microbiology | biochemical engineering | biological systems engineering | biology or chemistry | related life science or engineering discipline and a minimum of six years of relevant industrial experience OR
Master of Science degree in microbiology, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline and a minimum of four years of relevant industrial experience OR
Ph.D. in biochemistry, molecular biology, biochemical engineering, biological systems engineering, biology, chemistry or related life science or engineering discipline and one to two years of experience
- Annual Performance Incentives