Head Of Analytical Development

Job Title: Head of Analytical Development

Job Summary:

We are seeking a highly skilled and experienced Head of Analytical Development to lead our clients analytical development team in the advancement of release and characterization assays for identity, purity, strength, and potency. The successful candidate will be responsible for overseeing the development, validation, and execution of comprehensive analytical methodologies, as well as ensuring the implementation of robust laboratory controls and procedures. Additionally, this role involves strategic planning, collaboration with cross-functional teams, and management of departmental budgets.

Responsibilities:

1. Apply advanced scientific principles, theories, concepts, practices, and standards to analytical development of release and characterization assays for products.
2. Lead a team of scientists in the development of a comprehensive analytical understanding of products and related impurities throughout pre-clinical and clinical development.
3. Support routine testing for prioritized assays and projects, ensuring accuracy, reliability, and adherence to established protocols.
4. Establish and maintain appropriate laboratory controls and procedures for training, sample management, data integrity, reagent, and equipment management.
5. Build and expand laboratory capabilities aligned with short and long-term objectives.
6. Develop a strategic development plan across portfolio projects, ensuring consistency in the analytical development process.
7. Collaborate with process development, regulatory affairs, and other stakeholders to establish stability activities.
8. Contribute to the authoring, reviewing, and approval of briefing documents, IND, IMPD, BLA, and MAA sections, and participate in scientific advice preparations and meetings.
9. Collaborate with external laboratories (CMOs and CROs) to ensure robust method development, transfer, and execution in GMP and GLP settings.
10. Lead the technical review of analytical data, methods, stability protocols, and reports generated by internal and external laboratories to support clinical programs.
11. Author method development and qualification reports, test methods, and evaluate the suitability of new methods, overseeing method qualification and validation as needed.
12. Act as a cross-functional contact for developing a robust and integrated approach to therapeutic development.
13. Recruit, hire, and mentor staff, fostering an inclusive culture and developing an exceptional team.
14. Demonstrate care and appreciation for staff as a foundation for team development.
15. Establish and effectively manage the department's annual operating budgets.

Qualifications:

1. A strong scientific background, preferably with an advanced degree
2. Extensive experience in analytical method development and qualification.
3. Proven expertise in developing and implementing analytical methodologies for release and characterization assays.
4. Knowledge of relevant regulations and guidelines, including GMP and GLP requirements.
5. Experience in authoring and reviewing regulatory documents such as briefing documents, IND, IMPD, BLA, and MAA sections.
6. Demonstrated ability to lead and manage a team of scientists effectively.
7. Excellent problem-solving and decision-making skills, with the ability to prioritize and manage multiple projects simultaneously.
8. Strong communication and collaboration skills, with the ability to work effectively with cross-functional teams and external partners.
9. Experience in managing departmental budgets and resources.
10. A track record of fostering an inclusive and supportive work environment.

We offer competitive compensation and benefits packages, along with opportunities for professional growth and development. If you are a motivated and experienced analytical development professional looking to make a significant impact in a dynamic organization, we encourage you to apply.

Candidates without experience in Biotech/Pharma will not be considered.