Quality control senior scientist job description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.
* Perform routine laboratory testing and analyses of data.
* Execute test methods and protocols in the evaluation of medical devices, components, and materials.
* Provide support to method development and validation of methods.
* Perform data review (analytical, validation, investigations), review for compliance and identify issues, provide options for resolution.
* Read, understand, and interpret diverse procedures presented in a variety of written styles.
* Recognize errors, identify root causes, recommend process improvements.
* Bachelors in Science, engineering, or technology, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
* Five years of related laboratory experience
* Authorization to work in the United States indefinitely without restriction or sponsorship

Position is Monday-Friday, 8:00 AM - 5:00 PM. Candidates currently living in a commutable distance to Indianapolis, IN are encouraged to apply.

What We Offer:

* Excellent full time benefits including comprehensive medical coverage, dental, and vision options
* Life and disability insurance
* 401(k) with company match
* Paid vacation and holidays

Eurofins Lancaster Laboratories Professional Scientific Services (PSS) is a global, award-winning insourcing solution that places our people at our clients' site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client's quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

JOB OBJECTIVE: Develop, characterize, validate, and implement analytical methods for the manufacture of Active Pharmaceutical Agents (API).

CORE DUTIES:

1. Independently perform and oversee all aspects of analytical method development, method validation and method implementation.

2. Write, review and revise, as necessary, inspection plans, test methods, SOPs and other QC department procedures, for accurate and complete content, and ensuring they meet documentation policy.

3. Evaluate and interpret analytical testing results. Act as primary reviewer of analytical data generated from raw materials test, in process testing, and final product testing.

4. Collaborate with Manufacturing and R&D to develop analytical methods for API manufacturing.

5. Perform laboratory investigations for Out of Specification results or other testing abnormality. Investigate complaints from customers and internal deviations/nonconformances as assigned.

6. Report results of release testing according to company Quality System requirements. This includes the input of results into SAP Quality Module and issuing COA’s as needed.

7. Prepare and/or maintain QC testing materials, retention samples, and reference standards.

8. Maintain a working knowledge of QC Lab instrumentation and associated analytical methods utilized for product release testing.

9. Perform analytical method evaluation and/or re-validation upon request, as part of installation, operation, performance qualification efforts related to new or changed laboratory instrumentation.

10. Support internal and external customers to ensure that proper and timely execution of all aspects of the clinical analytical method life cycle.

11. Provide training on QC methods and instrumentation in the laboratory, as needed.

12. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.

13. Embraces and is open to incorporating Promega’s 6 Emotional & Social Intelligence (ESI) core principles in daily work.

14. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

KEY QUALIFICATIONS:

1. Master’s or Ph.D. degree in Analytical Chemistry. M.S. with 10+ years, or Ph.D. with 8+ years in a Quality Control lab performing method development, validation and implementation related to API testing.

2. Extensive knowledge on the use and troubleshooting of typical analytical instruments, including HPLC, NMR, GC, ICP-MS, MS/QToF, Karl Fisher, and XRPD.

3. Experience in all aspects of analytical method development, method validation and method implementation related to API testing. This includes experience with the use of statistical tools to analyze data.

4. Experience writing and reviewing Inspection Plans, test methods, SOPs and other QC Dept procedures, for accuracy and complete content, and ensuring they meet documentation policy.

5. Strong knowledge of current regulatory guidelines and cGMP requirements.

PREFERRED QUALIFICATIONS:

1. Ph.D. with 2+ years or M.S. with 8+ years’ analytical method development experience in pharmaceutical company.

2. Experience in preparing regulatory submissions and responding to regulatory inquiries.

PHYSICAL DEMANDS:

1. Ability to remain stationary for several hours at a time.

2. Ability to move about the building and labs while performing the tasks described above.

Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.

*In labs and health care facilities worldwide - HERE WE ARE*

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

In this role you will perform cell-based bioassays, ELISAs, and other biological methods in a GMP setting. In addition, you will support testing at external laboratories. Routine work includes release and stability testing, critical reagent qualification, method validation and transfer, critical reagent qualification, analyzing data, and authoring technical documents.

*Essential Functions: *

* Provide hands-on leadership and subject matter expertise by performing immunoassays and cell-based assays in a GMP environment to support product release and stability.
* Author SOPs and technical documents
* Support the development, technical transfer, and validation of late-stage assays for AAV-based gene therapy programs.
* Work independently to review and trend QC data
* Support QC deviations, investigations, analytical method performance trending and root cause analysis.
* Author sections of regulatory filings
* Train junior staff
* Maintain the QC Bioassay laboratory (ex. Instrument qualification and maintenance. Passage cells, qualify critical reagents, etc)
* Work with cross functional teams with both internal and external colleagues

At PPD, part of Thermo Fisher Scientific we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

To learn how PPD, part of Thermo Fisher Scientific can advance your career, apply now!

***This position requires long term eligibility to work in the US without sponsorship. Please note F-1 OPT Visas are not considered long term eligibility for this role.*

*#LI-CM3*

*Education and Experience: *

* Bachelor's degree in Cell Biology, Molecular Biology, Biochemistry or equivalent and relevant formal academic / vocational qualification
* Scientist: Previous industry experience that provides the knowledge, skills, and abilities to perform the job (With a Bachelor's degree comparable to 2 years, with a Master's degree comparable to 0-1 years).
* Senior Scientist: Previous industry experience that provides the knowledge, skills, and abilities to perform the job (With a Bachelor's degree comparable to 4 years, with a Master's degree comparable to 2 years).

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

*Knowledge, Skills and Abilities:*

* Experience in routine mammalian cell culture strongly desired.
* Experience performing immunoassays such as ELISAs required. Experience with PCR strongly desired.
* Experience with cell-based potency assays is strongly desired.
* Experience with statistical analysis preferred
* Ability and desire to work in a fast-paced environment
* Strong collaboration, team-working skills, and communication skills
* Independently motivated and detail-oriented with good problem-solving ability
* Strong communication, interpersonal and organizational skills

*Working Environment: *

PPD, part of Thermo Fisher Scientific values the health and well being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

* Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
* Able to work upright and stationary and/or standing for typical working hours.
* Able to lift and move objects up to 25 pounds.
* Able to work in non-traditional work environments.
* Able to use and learn standard office equipment and technology with proficiency.
* May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
* Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
* As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.

*Our 4i Values: *

Integrity - Innovation - Intensity - Involvement

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application - we'd love to hear from you!

**Job:** **Labs*

**Organization:** **US BU*

**Title:** *Scientist / Senior Scientist - QC , Analytical Development*

**Location:** *MA-Woburn-FSP Woburn, MA*


PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group