Contract Method Validation Jobs in Center Valley, PA

Ott Scientific

The Ott Scientific family of companies comprises Polysciences, Bangs Laboratories, and Ethos Biosciences. Together, we bring the whole of our experience with best-in-class facilities and scientific, technical, analytical, and manufacturing capabilities to serve customers around the globe. We deliver highly specialized products and services that support scientific discovery and innovations.

Polysciences

Polysciences technical operations and scientific laboratories offer custom synthesis, contract manufacturing and packaging, and laboratory products. We are proud to offer a broad range of products and tailored solutions for the life sciences, bioprocessing, microparticles, medical device, specialty chemical and eChem industries. We adhere to ISO13485:2016, FDA cGMP 21 CFR 820 regulations, and SOCMA’s ChemStewards® Management System. We believe the best scientific innovations are built through collaborations.

At Polysciences, Inc., we take chemistry beyond the ordinary.  We create and produce specialty chemicals for medical devices, gene therapy, vaccine development, pharmaceuticals, drug delivery, electronics, academic research, and personal care.  We need driven, detail-oriented team players to support our growing operations and customer base and identify further opportunities for growth.

We recently expanded our analytical laboratory and added numerous new instruments to accelerate new product development and support our growing product line.  We are now seeking an experienced Analytical R&D Supervisor to lead our R&D analytical team in this state-of-the-art facility.  The ideal candidate will lead a team of analytical chemists who collaborate with R&D synthetic chemists, customers, and our QC team.  Responsibilities include developing, documenting and validating reproducible analytical methods, along with further expanding our analytical capabilities.  The position also includes working closely with our R&D synthetic chemists to improve our understanding of reactions and solve problems encountered to improve products and processes. 

Responsibilities:

• Lead a team of 2 – 4 analytical chemists developing and validating cGMP analytical methods, and analyzing samples using LCMS, GCMS, NMR, GPC, FTIR, TGA, DSC, Viscometers, etc.
• Create an inclusive environment where team members are engaged, motivated, and increasing their analytical skills, knowledge, and analytical method development and validation capabilities in a regulated environment (ISO 13485).
• Write well-organized method development reports and protocols for method validation.
• Collaborate with R&D synthesis chemists to investigate and understand reaction outcomes, help solve issues encountered during synthesis route selection, process development, and scale-up.
• Lead preparation of proposals and timelines for developing and validating new analytical methods.
• Provide training and guidance for new methods being implemented or transferred to the QC team.
• Communicate with customers to help determine appropriate analyses for their products, refine analytical methods, and provide results in reports and presentations.
• Identify, recommend, and lead the purchase of instruments that further expand the team’s ability to understand reactions and increase the company’s product characterization capabilities.
• Communicate with equipment providers to select and purchase new instruments, refine analytical methods, schedule service, and troubleshoot equipment issues.
• Lead the maintenance and troubleshooting of instruments in the analytical laboratory to minimize downtime.
• Maintain a safe, clean, and organized environment in the R&D analytical laboratory.
• Coordinate with internal synthesis, analytical, QC and production teams to meet project and company objectives.
• Manage analytical project timelines and deliverables and provide updates on progress made and challenges encountered.

Education & Skills Required:

•  PhD in Chemistry – Organic chemistry or Analytical chemistry preferred.
• 3+ years’ experience developing and validating analytical methods in a ISO 9001 / ISO 13485 environment.
• 3+ years’ experience leading a team of analytical scientists developing and validating analytical methods
• Must have hands on experience working with at least 3 of cGMP analytical methods, and analyzing samples using LCMS, GCMS, NMR, GPC, FTIR, TGA, DSC, Viscometers, etc.
• Extensive knowledge of analytical equipment, analytical methods, and data analysis.
• Adept and experienced at maintaining and troubleshooting analytical instruments.
• Excellent communication skills with the analytical team, other internal teams, customers, reports, protocols
• Highly organized, detail oriented, and able to prioritize multiple tasks.
• Experience working directly with customers is preferred.
• Proficient with Agilent & Waters LCMS & GCMS software, Microsoft Word, Excel, Powerpoint.
• Team organization and motivation skills and experience

What We Offer

Culture

Great people

Peer to Peer Recognition

Broader, hands-on work experience

Clean and Modern Equipment & Labs

Fun company events

Competitive Wages & Generous Year-end Bonus

Comprehensive Benefits

4 Medical PPO Medical Plans with Telemedicine, Rx, & Vision

2 Dental Plans

Healthcare, Dependent care, & Commuter Flexible Spending Accounts

401(k) with company match

Financial Health & Wellness w/1:1 Coaching

Basic & Supplemental Life Insurance

Accident, Hospital Indemnity, & Critical Illness

Paid Time Off

Short & Long-term Disability

9 Paid Holidays

Must have legal authorization to work in the US and will not require sponsorship.

Polysciences is an equal opportunity employer. Drug-free workplace. Tobacco-free work site.

Polysciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law.  All employment is decided on the basis of qualifications, merit and business need.

Equal access to programs, services, and employment is available to all persons.  Those applicants requiring reasonable accommodation to the application process and/or interview process should notify a representative of the Human Resources Department.

Education & Skills Required:

• MS or PhD in Chemistry - Organic chemistry or Analytical chemistry preferred.
• 3+ years' experience developing and validating analytical methods in a ISO 9001 / ISO 13485 environment.
• 3+ years' experience leading a team of analytical scientists developing and validating analytical methods
• Must have hands on experience working with at least 3 of cGMP analytical methods, and analyzing samples using LCMS, GCMS, NMR, GPC, FTIR, TGA, DSC, Viscometers, etc.
• Extensive knowledge of analytical equipment, analytical methods, and data analysis.
• Adept and experienced at maintaining and troubleshooting analytical instruments.
• Excellent communication skills with the analytical team, other internal teams, customers, reports, protocols
• Highly organized, detail oriented, and able to prioritize multiple tasks.
• Experience working directly with customers is preferred.
• Proficient with Agilent & Waters LCMS & GCMS software, Microsoft Word, Excel, Powerpoint.
• Team organization and motivation skills and experience

What We Offer

Culture

Great people

Peer to Peer Recognition

Broader, hands-on work experience

Clean and Modern Equipment & Labs

Fun company events

Competitive Wages & Generous Year-end Bonus

Comprehensive Benefits

4 Medical PPO Medical Plans with Telemedicine, Rx, & Vision

2 Dental Plans

Healthcare, Dependent care, & Commuter Flexible Spending Accounts

401(k) with company match

Financial Health & Wellness w/1:1 Coaching

Basic & Supplemental Life Insurance

Accident, Hospital Indemnity, & Critical Illness

Paid Time Off

Short & Long-term Disability

9 Paid Holidays

Must have legal authorization to work in the US and will not require sponsorship.

Polysciences is an equal opportunity employer.Drug-free workplace.Tobacco-free work site.

Polysciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit and business need.

Equal access to programs, services, and employment is available to all persons. Those applicants requiring reasonable accommodation to the application process and/or interview process should notify a representative of the Human Resources Department.