Director of Bioconjugation
3 months ago
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The Director of Bioconjugation at Abzena Bristol site will be responsible for managing key client account programs, and overseeing key research, development and production operations related to antibody-drug conjugates, conjugated vaccines, oligonucleotide-protein conjugates, and other conjugated products. This scientific leader will utilize personal extensive experiences and recognized expertise to lead the Bioconjugation Development department for the advancement of science and technology in the business and accomplishment of the company goals.
Responsibilities
- Manage bioconjugation R&D, process development and analytical method development groups within the bioconjugation development department.
- Manage key client account programs and maintain strong and lasting business relationships and oversee the bioconjugation development from project ideation, bid defense, assignment, progression, and completion. Collaborate with the business development team to build a solid sales pipeline and have meaningful participation in all aspects of Abzena's business.
- Lead the implementation, improvement and use of company systems within the Bioconjugation development department such as but not limited to ELN, ERP, Chem Inventory, and training.
- Oversee the Bioconjugation Development department operations and plan resources to successfully deliver client and company projects from project assignment to completion.
- Manage technical input to GMP Batch Records and other Quality documents according to ICH and FDA guidelines.
- Manage the technology transfer inputs of PD processes into the GMP manufacturing suite and provide support during GMP operations as needed.
- Coordinate activities with QA/QC and Management for development of tox and GLP batches.
- Development and qualification of analytical methods and instruments needed to support PD and later GMP manufacturing.
- Partner with other departments on complex projects and collaborations.
- Propose key strategies for challenging projects with innovative solutions.
- Provide key leadership in the advancement of science and technology for the industry and business.
- Mentor group leaders for team building and career advancement.
- Perform at the highest professional standards.
- Communicate effectively with supervisors, colleagues, and subordinates.
- Direct the team members to comply with company's Safety/GMP/GLP/GDP guidelines and SOPs
- Participate as a team player in all aspects of the company business.
- Keep up to date with EHS, cGMP, scientific, and technical developments.
- Evaluation of lab practices for continuous improvement.
- Provide assistance in laboratory design and process capabilities.
- Evaluate the team performance.
- Make hiring decisions through vigorous candidate screenings and interviews.
Qualifications
- PhD in Biochemistry or Bioengineering, and 10 years of extensive experience in bioprocessing, bioconjugate therapies and biopharmaceuticals.
- Proven track record of drug discovery, development and manufacture with extensive CMC and GLP/GMP knowledge and experiences.
- Excellent oral, written and interpersonal skills in scientific and business communications and presentations.
- Possess excellent problem-solving skills and demonstrate a thorough understanding of protein chemistry, protein handling, purification and characterization.
- Ability to independently prioritize work assignments, and consistently demonstrate the ability to perform assigned tasks through rigorous data collection and applying analytical tests and instrumentation in the laboratory.
FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
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