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.
Ferring is on a mission to transform the treatment of bladder cancer with a novel, first-in-class intravesical gene therapy that provides patients with an alternative to bladder removal surgery. Our Uro-Oncology team is growing with a variety of rewarding opportunities in commercial, medical affairs and technical operations. If you are energized by the prospect of bringing the benefits of cutting-edge science to meet the needs of patients, we may have the perfect role for you.
The Scientist, QC Microbiology position leads and/or is actively participates in experimental design, method validation/qualification, equipment qualification and technical transfer activities of compendial methods related to raw materials and finished product. Performs routine (and non-routine) quality control testing of raw materials, in-process materials, drug substance, finished goods and stability samples.
This is your opportunity to play an important role in making available to patients a novel product that has the potential to revolutionize the treatment of bladder cancer!
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:
- Responsible for authoring development protocols, final summary reports, investigations, change controls, risk assessments, trend reports and training. Is the subject matter expert for all microbiological methods in accordance to cGMP guidelines.
- Highly knowledgeable with compendial requirements and familiar with lean six sigma principles. The Scientist will collaborate with the Manager, QC and Team Leaders in support of leading and providing direction to laboratory staff for maintaining effective and efficient department operations.
- Leads and performs experimental design, compendia method qualifications and assay transfers to ensure successful project transfer and performance in the laboratory.
- Executes microbiological methods using, but not limited to, Bioburden testing, Microbial Limits Testing, Antimicrobial Effectiveness Testing, Sterility Testing, and Bacterial Endotoxin Testing, and Microbial and Fungal Identification.
- Executes stability program including pulling, testing, submitting to external laboratories and protocol and report generation.
- Performs training of new hires and assists junior analysts with water sampling, environmental sampling – routine/batch, gas testing, gown qualification and media fills.
- Oversee environmental performance qualification of new cleanroom areas. Performs risk assessments and develops sampling plans and site maps for new cleanroom areas.
- Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance; performs data trending.
- Supports research laboratories on experimental design and method qualification of clinical or pre-clinical products.
- Perform configuration of new analyses, products and specifications in LIMS as necessary.
- Communicates with vendors for laboratory needs.
- Creates, reviews, and performs authorization of GMP data on paper, logbooks and in LIMS, including but not limited to test results and records, validation protocols/reports, method transfer protocols/reports, test methods, equipment records, process transfer activities, etc. Ensures adherence to regulatory agency requirements, ICH guidelines, Ferring standards and procedures.
- Monitors the life cycle microbiology instruments for preventative maintenance and calibration - ensuring conformance to specifications. Ensures lab equipment conforms to specifications. Oversees the execution of IQ/OQ/PQ of new purchased instruments in a timely manner. Troubleshoots instruments in the lab when necessary.
- Issues deviations, laboratory investigations, corrective actions change controls, and monitors effectiveness checks in LIMS and in QA-Track.
- Oversees QC document management and archival and inventory control of consumables, media and garments. Assist with the budget requests, processes purchase orders and capital acquisitions requests (CAR’s).
- Authors SOPs, test method, specifications, developmental protocols, method qualification protocols/reports, annual product reviews and technical reports as needed.
- Trains junior analysts and develops training plans and/or oversee training activities for groups. Trains Micro Associates on Technical Concepts and Methods. Develops new training materials for microbiological test methods.
- May perform other duties as assigned by QC Micro Management.
- Work weekends, overtime, on-call and holidays, as needed.
Requirements:
- Bachelor of Science Degree in Biological or Environmental Sciences from an accredited College or University is required. Master of Science degree preferred.
- A minimum of 8 years of QC laboratory (pharmaceutical or biopharmaceutical industry) with a Bachelor’s Degree or 4 years of industry experience with a Masters degree.
- Strong preference for experience in the following:
- Cell/Gene Therapy (CarT)
- TT Activities
- Cell-Based Assay (ELISA, PCR)
- Rapid Microbial Methods
- Working knowledge of Standard Operating Procedures (SOPs), analytical test methods, and generally accepted laboratory practices
- Expertise with performing laboratory investigations, change controls, and associated CAPA under limited guidance
- Knowledgeable in Labware LIMS configuration of new analyses and product specification.
- Microbiological method development, transfer, and validation experience is highly preferred.
- Subject matter expert for all microbiological methods in accordance to cGMP guidelines and compendial requirements and familiar with lean six sigma principles
- Knowledge of USP/EP/cGMP and ICH guidelines; Microbiology techniques and instrumentation; Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWise); Microsoft Office; Lean Six Sigma concepts; Lean Labs; project management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments.
Physical job requirements:
- Ability to stand on feet for up to four hours at a time,
- Be able to lift, push, and /or pull up to 25 pounds, and
- 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.
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 $61,750 to $143,000, 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 frontloaded yearly of 40 hours, or higher if state or local law requires; vacation time for full time employees to accrue between 112.5 and 150 hours yearly in the first four (4) years of employment, and additional accruals starting in the fifth (5th) year of employment; and 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. For roles that are not field-based, Ferring has a policy that allows employees to work up to two days from home and three at a Ferring site, weekly.
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 gender, race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, 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