Quality control-associate scientist job description

Associate QC Scientist (2nd Shift)
Contract to hire!!

Must haves:

• Bachelor s degree in science field with 0-3 years of experience
• Master s degree in science field with 0-2 years of experience
• GMP experience preferred
• Must be able to read and understand English-written job instructions and safety requirements.
• Has basic knowledge of the principles and concepts of a discipline (e.g., Biology, Chemistry)
• Applies technical skills to complete assigned work within own group/project team

• Location: Bloomington, IN
• Industry: Pharmaceutical
• Hours: Monday - Friday 2:30PM- 11PM
• Salary: Up to $31.74 (Paid Weekly - Benefits Available)
• Employment Type: 12 Month Contract (contract to hire)

Environment : This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply, and optimal performance of our products.

Job Scope:
A quality control (QC) scientist s primary duty is to provide quality control environmental monitoring, critical utility systems, in-process, finished products, stability, cleaning process, and analytical method validation testing according to SOPs, cGMPs and regulatory guidelines.

Job Characteristics:

• Performing and reviewing testing during phases of production, providing technical peer review of testing data.
• Writing/revising technical documents including laboratory procedures, protocols and technical reports.
• Independently utilizing microbiological or analytical instrumentation such as HPLC, GC, UV, ICP-MS, FTIR, TOC, CE, ICE, Karl Fisher, Sterility Isolator, Plate Reader.
• Performing testing using methodologies such as SDS-PAGE, western blotting, IEF, ELISA, PCR, EM, Endotoxins, Bioburden, Sterility and recognizing atypical/out of specification (OOS) results and perform investigation to determine root cause and implement corrective and preventive actions.

EOE/ADA

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Named Science's 2021 Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's 2021 Top Employers Survey.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2022, we became Great Place to Work-certified in the U.S. for the second year in a row. In 2022, we were also listed as the No. 2 company on the Best Workplaces in Biopharma™ List, Small and Medium, and one of the Best Workplaces in New York™️️, which recognizes companies headquartered in NY, NJ, and CT.

Insmed is seeking an Associate Scientist QC with broad knowledge and expertise in dd PCR, qPCR, immunoassays, cell-based assays, and other molecular biology assays. This individual will be responsible for building a QC laboratory and maintain the lab in GMP-compliant status to support product release. This role will be involved in developing, qualifying, and validating robust QC methods to support product release and characterization by collaborating with internal functions groups and external CDMO/CTLs. In addition, this individual will be responsible for management of test samples, stability program, and reference standards.

Additional representative responsibilities will include, but not necessarily be limited to, the following:

• Collaborate with research, analytical and process development teams to develop, qualify/validate molecular biology assays such as dd PCR and qPCR assays, immunoassays and/or protein chemistry assays for process monitoring and drug product release

• Collaborate with research, analytical and process development teams to determine critical quality attributes (CQAs), monitor process and method performance, and troubleshoot

• Develop timelines and protocols for assay transfers, qualifications and validations

• Establish specifications for drug substance and drug products

• Author, review, and approve QC analytical SOPs, protocols, and reports

• Ensure the timely execution of all routine QC testing, data review, and preparation of summary reports

• Perform quality management activities such as deviation, CAPA, change control, investigation of OOS, OOT and anomalous results

• Establish sample plans, manage in-process and release test samples

• Establish stability plans, manage stability tests and reference standards

• Manage QC laboratory, track critical reagents and logbooks, and ensure all the equipment is calibrated

• Establish laboratory and participate in hiring QC staff

Position Requirements (Required and/or Preferred Skills, Experience and Education):

• Master's degree in relevant discipline with a minimum of 3 years of relevant industry experience or bachelor degree with a mininum 5 years experience.

• Experiences in the pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing, with experience in a GMP QC release testing role

• Experiences in developing methods with particular emphasis on immunoassay, cell-based potency assay, molecular biology assay, and protein chemistry assays

• Significant experience in an FDA-regulated environment

• Entrepreneurial spirit, with strong willingness to take on new challenges required to bring novel medicines to the clinic

• Excellent organizational and communication skills

• Experience with direct reports or managing people

Up to 5% travel

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Please note that we review every submission, and we will keep all submissions on file for six months.

#LI-TC1

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.

As a*Scientist/Associate Scientist - QC Molecular Biology*, you will specifically support the client's gene therapy program pipeline including but not limited to technical transfer, method qualification and/or validation troubleshooting, and routine GMP testing of AAV vector analytical methods such as rc AAV GC titer determination by droplet digital PCR (dd PCR) and Quantitative PCR (qPCR), impurity testing, and other methods as needed. You will also support external laboratory testing and internal study protocol design, study report review and IND support as needed.
*Other essential responsibilities:*

* Support and/or lead the development, technical transfer and validation of qPCR and dd PCR-based assays and other methods for lot release and stability.
* Perform assays to generate characterization, release and stability data.
* Work independently to analyze, review, and trend QC data and generate stability and other trending reports as necessary
* Support the development of QC systems and SOPs to enable in-house QC release testing.
* Support QC deviations, investigations, analytical method performance trending and root cause analysis.
* Engaging with in-house cross-functional teams and external QC test labs and CMOs, oversee and manage: QC data review, method validation activities, protocol review and report finalization.

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.*

*Education and Experience: *

* Bachelor's degree in Molecular Biology, Cell 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 1 years).
* *Associate Scientist*: Previous industry experience that provides the knowledge, skills, and abilities to perform the job (With a Bachelor's degree comparable to 1 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.
* Hands-on experience with digital PCR (dPCR) and/or qPCR method development, qualification and/or validation required

*Preferred Experience:*

* QC GMP experience with extensive experience in Quality System operation is strongly desired.
* Experience with viral vectors is not required but experience with biologics preferred

*Knowledge, Skills and Abilities: *

* Hands-on experience with dPCR and/or qPCR method development, qualification and/or validation required
* Experience in drafting protocols, data reports and QC/QA compliance documents required
* Experience with statistical analysis of analytical data and stability studies preferred - JMP
* Proficient in Microsoft Excel and Word
* Ability and desire to work in a fast-paced, start-up environment
* Strong collaboration, team-working skills and communication skills
* Independently motivated and detail-oriented with good problem solving and troubleshooting abilities
* Proven ability to interpret data by performing trend analysis
* Proven ability in technical writing skills
* Good written and oral communication skills
* Time management and project management skills

*Working Environment: *

/PPD, part of Thermo Fisher Scientific values the health and wellbeing 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!

*#LI-CM3*

**Job:** **Labs*

**Organization:** **US BU*

**Title:** *Scientist / Associate Scientist - dd PCR , qPCR , QC*

**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