You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

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 medical, dental, vision, Life, LTD, retirement savings and more! Can we make this broader language, so it fits in all markets, e.g., 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 the Company

Snapdragon Chemistry, Inc. is a leader in chemical process development with expertise in continuous flow and process intensification technologies. Our company is catalyzing the transformation of research, development, and manufacturing across the pharmaceutical and fine chemical industries where synthetic chemistry underpins product development. In 2021 Snapdragon will commission a new 51,000 SF GMP manufacturing facility, enabling us to deliver GMP drug substances to our clients from the Waltham facility.

We rely on our most valuable resource – our people – to maintain a leadership position in this market. As part of our dynamic team, you will have the opportunity to collaborate with world-class leaders in flow chemistry and product development while also cultivating and furthering your career. 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 its Quality Assurance Associate Director / Director position – level to be determined based on experience. A successful candidate will be joining a highly innovative and entrepreneurial team of engineers and scientists seeking to advance pharmaceutical development and manufacturing.

We are looking for candidates who have a passion for the science of pharmaceutical manufacturing and excited to share the Snapdragon vision of future manufacturing. The ideal candidate will have at minimum a BS degree in scientific discipline and 7-10 years quality assurance experience.

Responsibilities

• Plan, coordinate, and direct quality assurance (QA) GMP activities in multi-product GMP facility to ensure consistent high-quality product manufacturing
• Working with QA staff to manage day-to-day QA activities for final disposition of products
• Write, review, revise, approve SOPs, MBR, etc
• Work closely with Facilities, CMC and Quality Control functions to manage Client site audits
• Manage quality technical agreements and quality questionnaires
• Manage Supplier and Vendor qualifications
• Responsible for internal audits, observations and responses
• Oversee training program. Conduct GMP training sessions
• Manage Quality Metrics to provide snapshot of status of QMS within Snapdragon
• Develop quality assurance plans by conducting risk assessments
• Responsible for ensuring Snapdragon products and services meet client and industry standards of quality

Qualifications

• BS degree in scientific discipline
• 7–10 years industry QA experience including managing GMP quality systems in the Pharma/Biotech industry
• Extensive knowledge of cGMP and ICH requirements for small molecule development and manufacturing, including drafting, interpreting, and implementing quality assurance policies and procedures as well as establishing document management activities
• Significant experience with establishing QMS solutions (especially for a multi-client environment), supporting on-site audits, and ensuring finished product quality
• Ability to independently assess R&D and manufacturing activities for compliance to regulatory standards for cGMPs, identify areas of non-compliance, recommend corrective action, as well as participate or lead team-based solutions.
• Demonstrated management/supervisory experience, with a history of developing a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives.
• Experienced, self-motivated individual who can handle multiple priorities to meet project team goals and timelines.
• Excellent communicator with strong leadership, presentation and influencing skills, and problem-solving ability.
• Experience in managing relationships with internal departments, external vendors, and clients in a collaborative manner.
• Excellent written and verbal skills and the ability to communicate clearly, concisely, and effectively.

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.