Specialist, QC Bioanalytical

Ferring Pharmaceuticals SA; Parsippany-Troy Hills (NJ); On-site; USD 77,000 - 143,000; Full time

Job summary

Ferring Pharmaceuticals in Parsippany, NJ is seeking a Specialist, QC Bionalytical to perform bioanalytical testing of raw materials, in-process samples and finished products, ensuring regulatory compliance and internal quality standards.

Responsibilities include conducting ELISA, PCR and HPLC assays, maintaining instruments, documenting results, and collaborating with R&D, Manufacturing and QA to drive product development and process improvements in a GMP environment.

Qualifications

• Bachelor’s or Master’s degree in biology, Cell and Molecular Biology, Biochemistry, Biological Chemistry, Pharmaceutical Sciences, or related field.
• A minimum of 2 years of experience in bioanalytical testing within a GMP, QC Analytical or in the biotechnology or pharmaceutical industry.
• Working knowledge following SOP
• Proficiency in ELISA, PCR, Flow Cytometry, Spectroscopy and HPLC (preferred).
• Understanding of regulatory requirements (FDA, EMA, ICH) for bioanalytical method validation and sample analysis.
• Strong problem-solving skills and attention to detail.
• Effective communication and interpersonal skills, with the ability to work collaboratively in a diverse team environment.
• Strong attention to detail, i.e., reviewing documentation for adherence to SOP format requirements; accurate data entry of documentation into a database.
• Punctual and having some flexibility in work schedule
• Comfortable to work in a cell culture lab area and viral based gene-therapy drugs.
• Proficient using Microsoft office such as Word, Excel, Powepoint and others

Responsibilities

• Conduct bioanalytical testing and analysis using a variety of techniques such as Cell-Based Assay, ELISA, PCR and HPLC.
• Perform assays for the quantification of biomarkers, proteins, nucleic acids, and other analytes.
• Execute routine QC testing, method validation, verification, and transfer activities in accordance with regulatory guidelines.
• Maintain and troubleshoot analytical instrumentation to ensure optimal performance and data integrity.
• Document test results, observations, and deviations accurately in laboratory notebooks and electronic systems.
• Collaborate with cross-functional teams including Research & Development, Manufacturing, and Quality Assurance to support product development and process improvement initiatives.
• Participate in investigations of out-of-specification (OOS) results and non-conformances, and implement corrective and preventive actions (CAPAs) as needed.
• Adhere to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Good Documentation Practices (GDP) in all laboratory activities.
• Contribute to the continuous improvement of laboratory procedures, protocols, and documentation.

Skills

Bioanalytical testing

GMP

GLP

SOP adherence

Data integrity

Microsoft Office

Cell culture knowledge

Education

Biology degree

Cell & Molecular Biology

Biochemistry

Pharmaceutical Sciences

Tools

LIMS

TrackWise

Job description

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 Specialist, QC Bionalytical , you will be responsible for performing bioanalytical testing and analysis of raw materials, in-process samples, and finished products to ensure compliance with regulatory requirements and internal quality standards.

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:

• Conduct bioanalytical testing and analysis using a variety of techniques such as Cell-Based Assay, ELISA, PCR and HPLC.
• Perform assays for the quantification of biomarkers, proteins, nucleic acids, and other analytes.
• Execute routine QC testing, method validation, verification, and transfer activities in accordance with regulatory guidelines.
• Maintain and troubleshoot analytical instrumentation to ensure optimal performance and data integrity.
• Document test results, observations, and deviations accurately in laboratory notebooks and electronic systems.
• Collaborate with cross-functional teams including Research & Development, Manufacturing, and Quality Assurance to support product development and process improvement initiatives.
• Participate in investigations of out-of-specification (OOS) results and non-conformances, and implement corrective and preventive actions (CAPAs) as needed.
• Adhere to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Good Documentation Practices (GDP) in all laboratory activities.
• Contribute to the continuous improvement of laboratory procedures, protocols, and documentation.

Requirements:

• Bachelor’s or Master’s degree in biology, Cell and Molecular Biology, Biochemistry, Biological Chemistry, Pharmaceutical Sciences, or related field.
• A minimum of 2 years of experience in bioanalytical testing within a GMP, QC Analytical or in the biotechnology or pharmaceutical industry.
• Working knowledge following Standard Operating Procedure (SOP)
• Proficiency in analytical techniques such as ELISA, PCR, Flow Cytometry, Spectroscopy and HPLC (preferred).
• Understanding of regulatory requirements (FDA, EMA, ICH) for bioanalytical method validation and sample analysis.
• Strong problem-solving skills and attention to detail.
• Effective communication and interpersonal skills, with the ability to work collaboratively in a diverse team environment.
• Strong attention to detail, i.e., reviewing documentation for adherence to SOP format requirements; accurate data entry of documentation into a database.
• Punctual and having some flexibility in work schedule
• Comfortable to work in a cell culture lab area and viral based gene-therapy drugs.
• Working knowledge with LIMS and Trackwise is an asset.
• Proficient using Microsoft office such as Word, Excel, Powepoint and others

Physical Requirements:

• Ability to stand, sit, and walk for extended periods.
• Ability to lift and carry up to 25 pounds.
• Ability to work in a laboratory environment with exposure to chemicals and biohazardous materials.
• Ability to wear personal protective equipment (PPE) as required, including lab coats, gloves, safety glasses, and respiratory protection masks.
• Flexibility to work occasional evenings, weekends, or additional hours, as needed, to support deadlines.
• Meet minimal visual acuity requirements necessary for quality assessments

Role will be in 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 $76,831 to $142,685, 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 15 paid holidays per year. We are proud to offer paid parental leave subject to a minimum period of employment at Ferring.

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, colour, 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 Affidavit Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace.

Location:

Parsippany, New Jersey