Head of Analytical Development and Quality Control

Cambrex; Boston; On-site; GBP 115,000 - 300,000; Full time

Job summary

Cambrex is seeking a Head of Analytical Development and Quality Control to lead a team of scientists at its Waltham, MA site. This senior role involves the development and oversight of analytical strategies for drug substance processes in a fast-paced environment. The ideal candidate will hold a Ph.D. in a relevant field and have significant leadership experience, driving innovation and ensuring quality control across projects.

Benefits

Healthcare

Life insurance

Retirement planning

Tuition assistance

Qualifications

• Minimum 12 years experience with a Ph.D., preferably in biopharmaceutical development.
• Established track record in analytical development supported by publications or patents.
• Proven ability to manage and mentor scientific staff.

Responsibilities

• Lead and develop the Analytical Development and Quality Control team.
• Collaborate across functions to deliver manufacturing processes and analytical methods.
• Participate in business development activities and strategic initiatives.

Skills

Leadership

Analytical chemistry expertise

Problem-solving

Communication

Education

Ph.D. in analytical chemistry or related discipline

B.S. or M.S. in Chemistry, Chemical Engineering or equivalent

Tools

HPLC

GC

Mass spectrometry

NMR

Job description

Head of Analytical Development and Quality Control

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Head of Analytical Development and Quality Control

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Senior Talent Acquisition & HR Business Partner at Cambrex & Snapdragon Chemistry| Recruiting & Developing Global Talent | Human Resources | CDMO |…

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.

With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!

About Snapdragon Chemistry

Snapdragon Chemistry was acquired by Cambrex in 2023 due to its innovative approach to chemical development and is now fully integrated into Cambrex. As part of our dynamic team, you will have the opportunity to collaborate with world-class leaders in process development and advanced continuous manufacturing technology for traditional small molecules and complex-synthetics. At Snapdragon Chemistry, we strive to create an environment of innovation and excellence where mutual respect and teamwork underpin our culture.

Job Description

Snapdragon Chemistry is currently seeking exceptional candidates for the position of Head of Analytical Development and Quality Control at its Waltham, MA site. The successful candidate will lead a growing team of 10-15 innovative and entrepreneurial scientists with broad deliverables including creating the analyses (tool and methods) and control strategies that drive Snapdragon Chemistry’s state of the art complex-synthetics route development. Additionally, they will lead and advance the Quality Control function, collaborating with Quality Assurance, Manufacturing, and our clients as Snapdragon Chemistry delivers GMP intermediates and drug substances for our clients who include top large pharmaceutical and innovative biotechnology companies.

We are seeking a candidate with exceptional leadership skills and scientific ability and experience working in drug substance process development who has a passion for working in a fast-paced, dynamic environment. A Ph.D. in analytical chemistry-related discipline with a strong entrepreneurial spirit and a demonstrated ability to take initiative and engage in innovative problem solving is critical. The ideal candidate will have experience in the development of small-molecule therapeutic candidates, supporting IND or NDA regulatory filings, and adept oversight of Quality Control laboratories and staff. Candidates should have extensive experience in the development of control strategies applied to pharmaceutical manufacturing. Experience in the development and transfer of analytical methods and the application of process analytical technologies in R&D and manufacturing settings is required. Candidates must possess strong written and oral communication skills and the ability to recruit and advance junior staff.

The Head of Analytical Development and Quality Control will be part of the senior leadership team of Snapdragon Chemistry, with the oversight of both analytical development activities and execution of Quality Control responsibilities. They will lead the analytical team, interface with their peer chemists and engineers, clients and external partners to design and develop practical, innovative, and phase-appropriate control strategies as applied to drug substance and fine chemical manufacture.

Responsibilities

• Lead and develop Snapdragon’s Analytical Development and Quality Control team
• Recruit, develop and manage scientific staff
• Collaborate across Snapdragon Chemistry’s other functions and with clients and partners to discover, develop and deliver practical manufacturing processes, analytical methods, and control strategies
• Oversee and participate in research activities to ensure that Snapdragon Chemistry’s laboratory team meets its research and development milestones and all other objectives
• Drive research and development activities that build upon Snapdragon Chemistry’s proprietary knowledge and technology to fulfill their value creation potential
• Participate in business development activities and strategic business initiatives
• Lead, manage, and work well with a team to accomplish complex deliverables within a stringent timeline
• Ensure that the integrity and profile of Snapdragon Chemistry within the scientific community are maintained at a high level, consistent with the requirements of the business.

Qualifications

Required Experience and Skills:

• Minimum 12 years with a Ph.D. (minimum 17 with a B.S. or M.S.) of experience with a proven track record of successful research, preferably with biopharmaceutical development experience
• An established track record of success in analytical development and science supported by publications, patents, and/or external presentations related to the field
• Experience working with or transferring analytical methods to quality control laboratories
• Demonstrated ability manage people and lead teams, drive research programs, and mentor
• Strong written and oral communication skills

Preferred Experience and Skills

• D. in Chemistry, Chemical Engineering or equivalent required
• Deep knowledge and experience in a range of analytical techniques including HPLC, GC, SFC, mass spectrometry, infrared spectroscopy, titrations, NMR as they are applied to drug substance process development and manufacturing
• Demonstrated ability to take initiative, be creative and innovative
• Experience and setting up processes to support regulated, drug substance stability programs for inclusion in regulatory filings
• The ability to be an enterprise leader delivering strategies and tactics that support the breadth of Snapdragon Chemistry’s functions
• Experience writing and reviewing standard operating procedures and work instructions that support established quality policies and procedures
• Ability to celebrate differences and encourage scientific openness and frank discussion
• Team-oriented and invested in the success of others
• Ability and demonstrated willingness to comply with, and encourage amongst others, the ethical and cultural standards of Snapdragon Chemistry

Education

• B.S., M.S., or Ph.D. in Chemistry, Chemical Engineering or equivalent required

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science, Research, and General Business

• Industries

  Pharmaceutical Manufacturing, Research Services, and Biotechnology Research

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Medical insurance

Vision insurance

401(k)

Tuition assistance

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