Job details

Senior Specialist, QC Microbiology

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 US is Great Places to Work® Certified. Earning this certification means that Ferring US is one of the best companies to work for in the country. Our people are at the core of what makes Ferring a great place to work. Putting people first, strengthening our workplace culture, and ensuring that it is a safe, equitable, and welcoming place to work is a priority at Ferring, and it always will be.

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.

Responsibilities:

Position is responsible to actively participate 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. Responsible for authoring development protocols, final summary reports, investigations, change controls, risk assessments and training. Is the subject matter expert for microbiological methods in accordance to cGMP guidelines.

Highly knowledgeable with compendial requirements and familiar with lean six sigma principles. The Senior Specialist will collaborate with the Microbiology Manager and Team Leaders in support of leading and providing direction of technology transfer activities to laboratory staff for maintaining effective and efficient department operations.

Support the transfer and provide technical oversight of Microbiological methods from Development to QC (validation of methods and tech transfer of methods).
Establish user requirements for purchase, qualification of QC equipment and work with internal and external resources to maintain equipment in an optimal state.
Develop, revise and review SOPs, qualification/validation protocols and reports.
Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures.
Develops new training materials for microbiological test methods. Trains team on technical concepts and methods.
Issues and investigates deviations, laboratory investigations, corrective actions, change controls, and monitors effectiveness checks in LIMS and in QA-Track.
Executes microbiological methods using, but not limited to, Bioburden testing, Microbial Limits Testing, Antimicrobial Effectiveness Testing, Sterility Testing, Bacterial Endotoxin Testing, Microbial and Fungal Identification, total plate count (TPC), Coliform and biological indicator.
Prepare and maintain microbial stock culture and perform Methods suitability (Bacteriostasis/Fungistasis (B&F)) testing.
Assist in EMPQ and on developing sampling plans and site maps. 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.
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.
Work weekends, overtime, on-call and holidays, as needed.
May perform other duties as assigned by management

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 4 years of QC laboratory (pharmaceutical or biopharmaceutical industry) with a bachelor’s degree.
Strong technical competency and knowledge of Regulatory guidance and regulations (cGMP, USP, EU, JP and the ISO regulation)
Working knowledge of Standard Operating Procedures (SOPs), analytical test methods, and generally accepted laboratory practices
Expertise with performing EM excursion investigations, deviations, OOS change controls, and associated CAPA under limited guidance
Experience with LIMS configuration of new analyses and product specification is a plus.
Microbiological method development, transfer, and validation experience is highly preferred.
Subject matter expert for microbiological methods in accordance to cGMP and GLP 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 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.
Occasionally moves equipment and/or supplies weighing up to 50 pounds within the facility.
Ability to work in & near operating equipment both large and small.
Ability to attain clean room gowning certification & work with hazardous materials, including disinfectants and sanitizers.
Frequent standing, bending, stooping & prolonged working overhead.
Occasionally ascends/descends a mezzanine staircase to take samples.
Able to do close precision work with hands to perform sampling tasks.
Flexibility in work schedule (Weekend, Holiday, Overtime as Required)

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 and perform pre-employment substance abuse testing.

Ferring offers a competitive total compensation package inclusive of but not limited to the following benefits: medical, dental, vision, 401(k), vacation policy, paid holidays, sick days, paid maternity/paternity leave, tuition reimbursement, flexible savings accounts, short-term disability, long-term disability, life and AD&D insurance.

Location:

Parsippany, New Jersey

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3.7

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CEO of Ferring Pharmaceuticals

Frederik Paulsen

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By Ferring Pharmaceuticals

Driven by its entrepreneurial spirit and enabled by a decentralised organisational setup, Ferring will harness its world-class competencies in science and business with other innovative technologies to create solutions for patients and doctors. By...

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FUNDING

Private

INDUSTRY

Biotech & Pharmaceuticals

TEAM SIZE

5001-10000

LOCATION

Hybrid, based in Saint-Prex, Switzerland

DATE POSTED