Analytical Development Lead
Beacon Hill Staffing Group

Job Info

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Position description:
Our client is seeking a Contract Analytical Development Lead to join our growing Pharmaceutical Development team. This role will report to the Head of Pharmaceutical Development and work closely with our network of CROs and CMOs to drive and oversee all aspects of analytical development for small molecules, including but not limited to stability assessment; method development and validation; and quality control activities occurring at these partner sites. The successful candidate will be responsible for transferring methods, protocol approval and execution oversight, and review and approval of data delivered from our network of laboratories. The Analytical Development Lead will interact closely with Quality Assurance, Chemical Development, Formulation development, and Regulatory to advance our growing portfolio of CNS penetrant compounds. This role will be remote allowing candidates from across the US to leverage our excellent virtual environment to collaborate with their colleagues. This opportunity is ideal for an individual with a strong analytical development background who seeks a new challenge and a great working environment.

Responsibilities:

• Maintain relationships with external labs and schedule and monitor work at these partner sites.
• Review and approval of analytical data and reports submitted by company's CRO/CMO network.
• Represent Analytical Development on multidisciplinary project teams, working collaboratively to ensure project progression and resolve technical challenges.
• Evaluate and trend stability data for drug substance and drug product and set retest, expiry, or shelf-life periods.
• Author technical reports and CMC sections of the regulatory filings (e.g. INDs, IMPDs, etc.).
• Work effectively with CROs/CMOs by providing technical oversight to develop and qualify/validate methods for drug substances and drug products.
  

Skills and behavioral expectations:

• Clear and effective written and verbal communication skills.
• Excellent organizational skills.
• Familiarity with current Good Manufacturing Practice regulations across the phases of development and a commitment to Quality.
• Excellent attention to detail.
  

Basic qualifications:

• BS, MS, or PhD in pharmaceutical sciences, pharmaceutics, chemistry, or related scientific field and 5+ years (8+ years for BS/MS) of industrial experience.
• Experience in executing drug substance and drug product method development and validation, stability assessment studies, and technical troubleshooting at external laboratories.
• Strong fundamental understanding of drug substance and drug product analytical methods and their importance in both developing process and product technologies and quality control of finished goods.
• Experience in reviewing and interpreting drug substance and drug product release and stability data.
• Effective and innovative problem-solving skills.
  

Preferred qualifications:

• Hands-on experience working in an GMP analytical development laboratory on drug product and drug substance development.
• Experience authoring sections for regulatory filings (e.g. INDs)
• Experience evaluating stability data for drug product and/or drug substance to set retest, expiry, or shelf-life.

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

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Company Profile:

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com.

We look forward to working with you!

Beacon Hill. Employing the Future™

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