Analytical Development Manager
Analytical Development Manager
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Salary Not Disclosed
1 Vacancy
Job Description
Our Work Matters
At Kindeva we make products that save lives ensuring better health and well-being for patients around the world.
The Impact You Will Make: As the Analytical Development Manager you will lead and oversee analytical activities supporting drug substance and drug product development across all phases of the product lifecycle. You will ensure successful development validation and transfer of analytical methods with a focus on scientific excellence regulatory compliance and cross-functional collaboration. Your leadership and technical expertise will be critical in advancing product development and regulatory submissions to deliver high-quality pharmaceutical products to patients globally.
Responsibilities:
- Lead and manage a team of analytical scientists responsible for developing validating and executing analytical methods for raw materials intermediates drug substances and drug products.
- Provide strategic direction and technical oversight for method development method qualification/validation and analytical troubleshooting.
- Oversee analytical support for formulation development process development manufacturing and stability studies.
- Ensure compliance with cGMP ICH and FDA guidelines in all laboratory operations and documentation.
- Review and approve analytical protocols technical reports specifications and CMC sections of regulatory submissions (IND NDA BLA etc.).
- Manage outsourcing of analytical activities to CROs and CDMOs including method transfer oversight and data review.
- Drive continuous improvement initiatives including implementation of new technologies and optimization of workflows.
- Support regulatory inspections and internal audits as an analytical subject matter expert (SME).
- Provide mentorship training and career development for direct reports to foster a high-performance team.
- Collaborate effectively with cross-functional partners in Quality Manufacturing Regulatory Affairs and Project Management.
- Support qualification of new analytical laboratory equipment.
- Utilize creative thinking to generate solutions to complex technical problems.
- May be required to travel to attend or present at industry conferences.
Qualifications:
- Degree in scientific field: BS with 11 years experience MS with 8 years experience PhD with 6 years experience
- 2 years in a supervisory role
- Extensive knowledge of analytical techniques including HPLC/UPLC GC MS UV FTIR compendial methods etc.
- Strong understanding of regulatory and compliance requirements for analytical methods in pharmaceutical development and manufacturing.
- Experience authoring and reviewing analytical sections of regulatory submissions.
- Proficiency in analytical software systems (e.g. Empower LIMS CDS).
- Proven ability to lead teams manage multiple priorities and deliver results on time.
- Excellent written and verbal communication skills with demonstrated success in cross-functional collaboration.
- Strong organizational skills and attention to detail.
- Experience with both small molecules and biologics a plus.
- Familiarity with analytical Quality by Design (QbD) risk assessments and statistical data analysis.
- Direct experience supporting regulatory agency inspections or audits.
Physical Requirements:
- Employee is required to regularly use hands to handle materials and supplies.
- Employee is required to use computers for an extended period each day.
- Employee is required to effectively use communication by both telephone and electronic means.
- Employee is required to regularly stand and walk for extended periods.
- Employee must occasionally lift and/or move up to 25 pounds.
- Ability to use proper lifting techniques and be conscious of work area hazards.
- Employee is required to follow all site safety procedures.
Required Experience:
Manager
Employment Type
Full-Time
