AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

 

SUMMARY:

This is a Senior/Principal Development Scientist position in the Analytical and Formulation Development group.  Primary responsibilities include protein formulation development, process development for GMP manufacturing, client management and technology development. We are seeking an experienced and highly motivated protein formulation scientist to head a formulation group within the Analytical and Formulation Development department. 

 

 

PRINCIPAL RESPONSIBILITIES:

  • Coordinate formulation development activities leading to clinical and commercial manufacturing for multiple client projects.
  • Work with clients and internal project teams in the successful completion of contract manufacturing projects.
  • Present data at client project team meetings and provide written reports.
  • The successful candidate will manage a group performing studies for protein pre-formulation, liquid and lyophilized formulation development and optimization, comparability, photostability, and materials compatibility.
  • Contribute to the overall operation of the lab and infrastructure improvements.
    • Provide technical support in the laboratory as necessary.
    • Implementation of new equipment and technology.
  • Provide technical and strategic planning support to business development activities with respect to new client projects and new business initiatives.

 

KNOWLEDGE, SKILLS & ABILITIES:

  • Background in analytical and formulation development of biologics.
  • Extensive Management experience of a scientific staff.
  • Excellent technical writing and presentation skills.

 

EDUCATION/EXPERIENCE:

  • PhD in Biochemistry, Chemistry or a related subject, with at least 8 years relevant experience.
  • Expertise in the design, preparation and evaluation of liquid, frozen and lyophilized formulations of antibodies and non-antibody proteins in early and late stage development.  Ability to apply DoE approaches to study design.
  • Experience in development and use of protein analytical methods to evaluate formulated protein products. Experience must include DLS/SLS, isoelectric focusing, and UHPLC methods (reversed phase, size exclusion and ion exchange).  Experience with additional tools for protein characterization, such as biophysical methods, CE, and ELISA, would be an advantage. 
  • Proven managerial and supervisory skills. Effectively mentors and develops employees.  Encourages employee ideas for enhancing operational excellence.
  • Ability to adapt plans rapidly in response to customer requests or technical problems. Flexibility, excellent organizational skills and strong scientific problem solving skills are required to enable successful execution of critical studies against tight deadlines.
  • Strong data management skills and attention to detail in the execution and documentation of studies.
  • Excellent oral and written communication. Ability to produce clear and accurate presentations and reports based on large amounts of data.
  • Strong leadership and team skills. Ability to build a good relationship with external clients.  Track record of success in coordinating with others to achieve formulation goals against timelines.
  • Entrepreneurial aptitude with creativity and interest in growing a contract manufacturing business.

 

COMPENSATION RANGE:

$148,917 - $180,000 annually

 

Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.

Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.

Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company’s performance and the Team Member’s performance.

 

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

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