Director, Manufacturing Operations
The highly motivated candidate will lead and build a team focused on the development of next generation antibody fragment imaging agents. The successful candidate will have extensive experience in conjugating proteins with a variety of moieties including chelators, drugs and fluorophores and performing appropriate analytical characterizations. The candidate will interface with chemists, biologists, vendors and clients in developing new technologies as well as optimizing current strategies. In addition, the candidate will support process and analytical transfers to pilot and commercial facilities to produce clinical materials ensuring that scalable processes are developed and ready for validation. The candidate will interact with in-house research groups, manufacturing and quality teams and oversee activities at outsourced CROs/CMOs.
Essential Responsibilities include but are not limited to:
- Assume leadership of a team focused on developing Antibody fragment product development
- Provides supervision, and scientific and technical input into antibody fragment conjugation programs.
- Ensures delivery with the team, the technical aspects and analytical characterization of antibody fragment conjugation programs, as well as to support process and analytical transfers to pilot and commercial facilities for the production of clinical materials, ensuring that scalable processes are developed and ready for validation
- Ensures internal product development meets worldwide regulatory requirements.
- Responsible for optimizing production of products manufacturing.
- Directs the development, planning, and implementation of product and process development for new products and technologies from the laboratory through pilot plant and manufacturing scale.
- Assures compliance with GMP and National Regulatory Commission (NRC) regulations, operations budget including capital requirements.
- Facilitates technology and manufacturing process transfer.
- Provides product for applicable clinical trials as required to support US NDA file
- Reviews technical and clinical documentation and recommends changes for labeling, manufacturing, and clinical protocol for regulatory compliance.
- Represents departmental activities as needed, including project teams, task forces, audits and business or technical meetings.
- Communicate results in a timely manner and collaborate with internal and external development teams.
- Requires a PhD in Biochemistry, Molecular Biology or Chemistry, or a closely related field
- A minimum of 10 or more years’ experience working with proteins, antibodies, and conjugation technologies.
- Experience in the Supervise of staff, and be familiar with all duties associated with the operation of an effective research laboratory.
- Supervisory experience and experience with coordinating activities with CMOs. Experience, agreeing work plans, production schedules, and negotiation of manufacturing contracts
- Familiarity with appropriate Clinical trial directives, associated GMP and ICH guidelines regarding the manufacture of clinical trial material and final approved products
- Experience or knowledge of chelation chemistry and radiolabeling of proteins is desirable but not required
- Direct experience in purification of conjugated antibodies to small molecules, and process scale-up.
- Experience with HPLC, LC/MS-ESI and other chromatographic techniques ELISA, SDS PAGE, IEF, HPLC, WESTERN, BCA, and other pertinent biological and biochemical assays
- Hands-on experience with unit operations such as lab and pilot-scale bioreactor operation, chromatography, UF/DF, and filtration
- Supervisory experience and experience with coordinating activities with CMOs
- Must be highly motivated with excellent organizational and communication skills
- Must be able to work independently and as part of a multi-disciplinary team.
Technical Skill Set (Broad scientific areas of expertise)
- Antibodies (diagnostic and therapeutic)
- Clinical development of biologics
- Targets and applications in oncology
- Targets and applications in immunology
- Radiotracers for imaging by PET (a plus)
Personal and Leadership Qualities
- Committed to the company’s vision and have aptitude for an “early stage” environment.
- Strong leader based on sound scientific foundation, with the ability to strategize and prioritize.
- Ability to work within a budget and deadline and fiscally disciplined.
- Project management skills, with an ability to effectively motivate diverse members of the scientific team, individually and collectively.
- Performance management experience, benchmarking, mentoring, skill set development.
- Excellent communicator who is capable of traveling to present and effectively advocate the company’s science in a variety of settings (conferences, business development).
- Understanding of the dynamics of a venture-backed company.
How to Apply
If you are interested in this opportunity, please forward your CV to email@example.com. Please include the Job Reference Number: 150-IA2018 in the subject of the e-mail. Emails without a job reference number will not be considered.
ImaginAb is an equal opportunity employer. Health, dental, vision, life insurance, and 401K benefits are offered to full time employees. The company is currently unable to facilitate visas for non-US citizen/resident applicants at this time. All expressions of interest are considered in confidentiality. We thank all applicants who apply, but only those candidates selected for an interview will be contacted.