Senior Method development scientist-Biomarker LC-MS/MS
Title: Senior method development scientist- Biomarker LC-MS/MS
Location: 700 Pennsylvania Dr. Exton, PA
Reports to: SVP, Central Lab, Biomarker, and Biologics Services
Full-time/on-site
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position/Job Summary:
The Senior method development scientist supports method development using LC-MS/MS platform for large molecules (biomarkers, proteins, antibodies, ADCs, Oligonucleotides, etc). The senior method development scientist will be a member of the method development team, the responsibility includes serving as subject matter expert when new proposal is received, reviewing the client request and evaluating the feasibility of the project, developing the method after the contract is signed, transferring the developed method to the validation team, and troubleshooting for challenging method.
Roles & Responsibilities:
- Develop method using LC-MS/MS platform for large molecules (Proteins, antibodies, ADC, Oligonucleotides, Liposomal drugs, biomarkers, etc) quantitation in biological matrices.
- Facilitate the method transfer from the Method development team with the method validation team.
- Communicate project timelines, status, and data to Principal Investigator effectively addressing any issues that may arise.
- Ability to work on multiple projects at the same time.
- Research literature and external sources and identify new techniques and procedures that strengthen Frontage’s capabilities.
- Maintain the proper level of regulatory compliance. Ensure that GLP regulations and SOPs are followed in all bioanalytical service activities.
- Help with training and/or mentoring of junior scientific staff.
- Set-up, utilize, and maintain complex instrumentation Follow safety precautions.
Education, Experience & Skills Required:
- Ph.D. or Master’s degree in Analytical Chemistry, Biochemistry, Biology or related scientific discipline.
- 6-10 years of direct experience of bioanalytical method development for large molecules using LC-MS/MS in the biotech, pharma or CRO industry.
- Demonstrated experience in mass-spectrometry method development for antibodies including LC-MS intact protein analysis, peptide mapping, conjugate analysis etc.
- Demonstrated experience in small molecule and protein mass-spectrometry of quantitation of antibody drug-conjugates (ADC), including total Antibody, Conjugated payload, and free payload.
- Experience with Oligonucleotides and liposomal drug quantitation using LC-MS/MS is a plus.
- Proven ability to successfully work in a team environment. Excellent oral and written communication skills.
- Good knowledge and application of GLP with the ability to train technical personnel.
- Efficient time management.
- Strong troubleshooting and analytical skills.
- Detail oriented and meticulous.
- Ability to work independently under time constraints.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Skills Required
- Ph.D. or Master's degree in Analytical Chemistry, Biochemistry, Biology or related scientific discipline.
- 6-10 years of direct experience of bioanalytical method development for large molecules using LC-MS/MS.
- Demonstrated experience in mass-spectrometry method development for antibodies.
- Proven ability to successfully work in a team environment.
- Good knowledge and application of GLP regulations.
What We Do
Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and file regulatory submissions in the United States, China and other countries.
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