Director, Analytical Research & Development

The Director, Analytical Research & Development, will lead the analytical development activities of client projects including small molecule linker payload, APIs, intermediates, monoclonal antibodies, proteins, antibody drug conjugates and other therapeutic modalities. Responsible for analytical method development/qualification, product characterization, leading the teams, preparing the presentation for the client meetings and supporting the management team in other activities as needed. He/she will contribute to setting analytical strategy, working with clients on analytical work strategies, and in partnership with internal and external Quality colleagues to play key role in the development. The incumbent works cross-functionally with internal departments and external resources on Analytical Research & Development related issues. He/ she manages direct reports. The Director, Analytical Research & Development ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. 

• Working closely with clients, monitoring client projects and addressing technical challenges in a timely manner.
• Provide strategic, managerial, and technical leadership to the Analytical Development team.
• Design and execute phase-appropriate analytical strategies, including method development, qualification, and validation for ADCs and small molecule drug substances and drug products.
• Lead a team of 4 to 6 senior/principal/group leaders.
• Complex data interpretation, perform statistical analyses, summarize the results, and effectively present data internally and externally.
• Develop and set specifications for raw materials, intermediates, drug substances, excipients, and drug products.
• Establish and manage stability programs for non-GMP and cGMP drug substance and drug product batches.
• Lead the analytical development projects, prepare the teams for client meetings, and review the presentations with the scientists before presenting with clients.
• Lead method development and qualification/validation of physical chemical analytical methods for oligonucleotide, mRNA, mAb, ADCs and linker payload characterization, release, and stability testing
• Manage analytical method transfers from clients for clinical phase GMP testing, and support process technology transfer to cGMP.
• Manage relationships with existing and new clients, including managing timelines and cost for the analytical development in support of manufacturing activities.
• In collaboration with Quality Control, set product release and stability/shelf-life specifications
• Support business development and proposal management teams in writing new proposals and pricing for potential new clients.
• Working on new technology opportunities to support client projects.
• Author, review and approve relevant analytical test methods, qualification/validation/method transfer protocols and reports.
• Author, review and approve relevant Analytical and quality control and other quality related SOPs.
• Manages, coaches, and mentors direct reports
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills and Abilities:

• Knowledge of control strategy for large molecules, drug substance and drug products, phase appropriate method qualifications.
• In-depth mass spectrometry expertise and experience in characterization of ADC’s, mAb’s, proteins and their associated variants and impurities is required.
• In-depth understanding of product characterization of large molecules including ADCs’, monoclonal antibodies and proteins
• In-depth technical understanding of early and late-stage development of ADC products, including CMC Regulatory, Process/Analytical Development, and GMP Manufacturing and QC release and stability testing.
• Leadership and management experience of internal departments.
• Proven leadership experience and understanding influence skills with the desire and ability to work in a fast-paced, collaborative environment. Strong collaboration and team building, communication, and organizational skills required.
• Ability to influence without direct authority.
• Demonstrated leadership ability and experience managing, coaching and mentoring direct reports
• Proficiency with Microsoft Office
• Excellent verbal and written communication skills
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills include the ability to support and prioritize multiple projects.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil business needs.

Education and Experience Requirements:

• PhD or MS in chemistry, biochemistry, molecular biology, or chemical engineering with 10+ years of analytical development experience working in the Pharmaceutical or Biotechnology industry.
• Must have experience in developing, optimizing, troubleshooting, qualifying, and validating HPLC methods (SEC, RP, IEX, HIC etc.), for small molecules and/or large molecules characterization in cGMP environment.
• Hands on experience in analytical method development for ADC’s and small molecule linker payload including HPLC and mass spectrometry-based methods.

Physical Demands:

• Stand for extended periods of time with periodic stooping/bending / kneeling.
• Able to lift, push, pull up to 50lbs.
• Work in a lab environment requires special protective clothing over the head, face, hands, feet, and body. This role requires the ability to wear personal protective equipment.

Working Conditions:

Laboratory and Office environment

Certificates & Licenses Required:

N/A

Compensation:

$150,000- $170,000 per annum

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.