Head of Analytical Development

Head of Analytical Development
If culture and mentorship are your priorities – you’ve found your match. This pioneer company in Immunoncology is looking for a talented Head of Analytical Development who will establish and deliver a phase-appropriate analytical control strategy. The ideal professional will have a strong background in analytical operations for cell therapy and/or vaccines and an eagerness to join and contribute to a tight knit, mutually supportive community of skilled experts.

What you will do:

• Establishing a Quality Target Product Profile (qTPP) to establish our product’s Critical Quality Attributes (CQA) and control strategy.
• Ensure analytical methods are compliant, in control and maintained in a qualified/validated state
• Establish phase-appropriate product and impurity characterization plan
• Work closely with the CMC team to author and review regulatory submission documents and respond to information requests and regulatory questions.

Who you are:

• Degree in Chemistry, Biochemistry, or similar with 10+ years of experience.
• Extensive knowledge of QC methodologies, regulatory requirements and industry best practices
• Demonstrated technical leadership skills with the ability to manage and develop high-performing teams
• Strong knowledge of FDA, EMA, ICH regulations and USP, EU, and JP requirements

What does this position pay?

• Compensation is determined by several factors which may include skillset, experience level, and geographic location. The expected range for this role is $190,000 to $250,000 per year. Please note this range is an estimate and actual pay may vary based on qualifications and experience.

Please email your resume to sshields@provenrecruiting.com if you’d like to work alongside some of the finest scientists in the pharmaceutical industry!

Note: We actively support and promote people of various backgrounds, from race, religion, gender to geographical area, university, lifestyle, and personality type. Proven Recruiting is minority-owned, majority women, and is a strong advocate for diversity and inclusion in the broader community. Apply today!

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