Analytical Chemist, Biologics Jobs

Overview:

The Analytical Chemist (Biologics) will report to the Vice President of CMC Development and Project Management. In this role, the Analytical Chemist will support the drug development programs for biopharmaceutical clients, working closely and effectively with CROs and CMOs to manage outsourced analytical development work. This work includes oversight of analytical method development, validation, and transfer efforts.

Position Requirements:

• Ability to independently provide requisite analytical support in a phase-appropriate manner.
• Highly skilled in managing relationships with CROs, CMOs, and testing labs.
• An advanced knowledge of clinical study design and CMC processes.
• Additional experience in scientific roles is a plus.
• An advanced knowledge of drug substances and drug product development.

Responsibilities:

• Set drug substance and drug product specifications; oversee the development of cell-based assays; and design and analyze stability studies for intermediates, drug substances and drug products.
• Generate appropriate validation protocols.
• Collaborate with cross-functional project teams to present and solve critical analytical issues as well as meet product development milestones and regulatory filing timelines.
• Author and review CMC sections related to analytical methods and method validation, specifications, and stability in IND/NDA/BLAs, IMPD/MAAs, and other regulatory submissions.
• Identify critical in-process-control issues and develop appropriate IPC methods.
• Assign and justify retest and expiry periods as well as storage and shipping conditions.
• Work closely and effectively with CROs and CMOs to manage outsourced scientific analytical tasks including support of drug substance synthesis, formulation development, stability studies, method development, method validation, troubleshooting, and method transfer.

Necessary Experience & Education:

• Ph.D., M.S., or B.S. in Chemistry (or relevant discipline).
• A minimum of 5 years of relevant experience in ANDA/NDA/BLA pharmaceutical product development.

Who we are:

Syner-G BioPharma Group is a trusted development partner applying innovative and scientifically driven approaches to drug development. The entire Syner-G organization is built around the premise of guiding small molecule, biologics, and cell and gene therapy innovators through drug development, from pre-approval through post-approval, via the application of our integrated services including CMC support, medical writing, regulatory strategy and regulatory operations. Our industry leading solution, CMC 360™, is a fully integrated suite of CMC solutions that encompasses pharmaceutical development, regulatory services, quality/cGxP compliance, and IT systems. Our expertise spans small molecules, peptides, oligonucleotides, biologics, monoclonal antibodies, antibody-drug conjugates, and cell and gene therapy products.

As an employee, you will experience us leading with our core mission, “To develop and inspire pharmaceutical consulting professionals”. We encourage open, two-way communication throughout the company and provide a supportive and encouraging working environment that allows employees to reach their greatest potential, celebrating those who live our values every day. We realize the vital role a positive work/life balance plays in establishing a rewarding, productive, and long-term career. As a result, a flexible, family-friendly work environment is a key element of our culture and is one of the reasons people want to work (and stay) here!

We offer an outstanding total rewards package, including a competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous unlimited paid time off program, 13 paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”.

Syner-G BioPharma Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.