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Manager, QC Bioanalytical

Ferring Pharmaceuticals

Ferring Pharmaceuticals

Parsippany-Troy Hills, NJ, USA
Posted on Tuesday, April 23, 2024

Job Description:

As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease.

As Manager, QC Bioanalytical you will be responsible for overseeing the bioanalytical operations within the manufacturing plant, ensuring the quality and integrity of bioanalytical data to support manufacturing processes and product quality. This role requires strong leadership skills, technical expertise in bioanalytical methods, and a thorough understanding of regulatory requirements in a manufacturing environment.

With Ferring, you will be joining a recognized leader, identified as one of “The World’s Most Innovative Companies” by Fast Company, and honored by Fortune with inclusion on its “Change the World List,” for addressing society’s unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country.

Responsibilities:

  • Lead and manage the bioanalytical team within the manufacturing plant, providing guidance, direction, and support to achieve departmental goals and objectives.

  • Develop and implement bioanalytical strategies and processes to support manufacturing operations, including method development, validation, and sample analysis.

  • Collaborate with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs, to ensure alignment of bioanalytical activities with manufacturing objectives and regulatory requirements.

  • Lead and manage a team of bioanalytical scientists, fostering a culture of collaboration, innovation, and excellence. Define expectations, hold individuals accountable and recognize accomplishments, including professional development of direct reports, through combination of coaching, mentoring and effective development planning.

  • Monitor and evaluate bioanalytical data generated within the manufacturing plant, ensuring accuracy, reliability, and adherence to Good Manufacturing Practices (GMP) and other relevant regulations.

  • Manage resources, including budget, staffing, and equipment, to optimize efficiency and productivity within the bioanalytical department.

  • Oversee the execution of bioanalytical studies to assess the quality and stability of raw materials, intermediates, and finished products, ensuring compliance with established protocols and regulatory guidelines.

  • Lead investigations and/or change control strategies for processes. QC lead for discussions regarding investigations/nonconformances/ OOS/ OOL as they relate to studies and testing. Advises, recommends, and implements resolutions for quality problems and regulatory commitments to site management.

  • Identify opportunities for process improvement and optimization within the bioanalytical department, implementing best practices and technologies to enhance efficiency and productivity.

Requirements:

  • Bachelors degree in analytical chemistry, biochemistry, pharmaceutical sciences, or related field.

  • 5+ years’ in Pharmaceutical industry with emphasis in bioanalytical method development and validation within a, cGMP manufacturing environment, with at least 2 years in a leadership or management role.

  • Proficiency in bioanalytical techniques, including chromatography, spectroscopy, and immunoassays, as well as familiarity with relevant instrumentation and software.

  • Strong understanding of regulatory requirements for bioanalytical testing in a manufacturing setting, including FDA guidelines.

  • Strong understanding in the dependencies across QC and QA.

  • Proficient with Quality systems (OOS, OOL, Deviations, CAPAs, CCs,)

  • Experience in working in method Development and/or Quality Control functions at site and/or global level.

  • Knowledge of current industry trends in the regulated environment.

Physical Requirements:

  • The job may require standing and walking for extended periods, especially when supervising laboratory activities or conducting inspections within the quality control (QC) bioanalytical area.

  • May need to lift and carry laboratory supplies, reagents, and equipment weighing up 20lbs, typically within safe lifting guidelines.

  • May spend significant time sitting at a desk or workstation, reviewing data, writing reports, and conducting administrative tasks related to QC bioanalytical operations.

  • Must wear appropriate PPE, including lab coats, gloves, safety glasses, and respiratory protection, as required by standard operating procedures and regulatory guidelines.

  • The ability to move around the laboratory facility and navigate various work areas, including laboratory benches, equipment rooms, and storage areas, is essential for overseeing QC bioanalytical activities effectively.

  • Occasionally, the manager may need to work extended hours or weekends to meet project deadlines, address urgent issues, or oversee critical QC bioanalytical activities.

Location: Parsippany, NJ.

Ferring + you

At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry’s most impressive people, these are just some of the ways we live our "People First" philosophy.

Our Compensation and Benefits

At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $95,000 to $145,000, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.

Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long-term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, sick time of 1 hour per 30 hours worked, vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment as well as 12 to 13 paid holidays per year. We are proud to offer 26 weeks of paid parental leave, learn more about the parental leave offering in our benefits package here.

Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws.

Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.

We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace.

Location:

Parsippany, New Jersey