Job Title: Principal Scientist, Molecular Biology
Reports To: VP, R&D
Position Location: Buffalo, NY
Type of Employment: Full-time (Permanent)
FLSA Status (Exempt/Non-Exempt): Exempt
Position Summary:
This Principal Scientist will work in a technical area requiring hands-on work in a life sciences laboratory setting and will work as a team member in a fast-paced, deadline driven environment with tangible goals. Provides leadership for group and works closely with the team to ensure day-to-day operations are performed. Maintains rigorous quality mindset and advocates strict adherence to compliance practices within the department. Possesses rigorous scientific skills in the specific science area and a strong working knowledge of the technical and Good Laboratory Practice (GLP) / current Good Manufacturing Practice (cGMP) compliance requirements for testing. Remains current regarding testing requirements and develops / modifies methods to fully address such issues. Remains current in the scientific areas of Molecular diagnostics to help guide new product development. Provides supervision and direction of and is accountable for the productivity and budget adherence for the department. Works with internal groups and customers to ensure timely delivery.
Key Responsibilities:
- Ensures IVD product launches are on-time, high quality and market relevant.
- Provides strong in-house guidance on science and technology.
- Interacts with internal staff and customers to identify new and existing molecular products requiring further improvement or development and oversees improvement of these products
- Presents technical seminars at external professional meetings.
- Responsible for development of processes (testing and documentation) in accordance with GLPs or cGMPs.
- Ensures that laboratory personnel are following all company SOPs and safety rules.
- Oversees the operation of the new product development group ensuring timely results, adherence to budget and personnel management.
- Oversees the preparation and revision of technical documents (Client Protocols, SOPs, etc.)
- Assures that batch records and other paperwork are completed according to GLPs/ cGMPs and company SOPs.
- Collaborates with other Operations and PHL site teams to ensure project timelines are met.
- Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
- Participates in the candidate selection process; trains, evaluates, and enforces discipline when necessary.
- Motivates, and mentors employees to provide attentive, efficient service to customers and/or stakeholders.
- Assesses employee performance and provides helpful feedback and training opportunities.
- Performs other duties as assigned.
Education:
- Master’s degree in Biological Sciences or science related field or equivalent experience (Ph.D. highly preferred)
Experience:
- 0-5 years plus experience in a lab or similar environment with direct experience at launching IVD products.
- No industry experience is required for exceptional candidates with applicable educational/academic research experince.
Minimum Requirements/Qualifications:
- Knowledge of IVD and product development is required.
- Advanced knowledge of molecular diagnostics industry including tests and instruments.
- Formal training in one of the following main fields of study; Molecular Biology, Cell Biology, Biochemistry, or Microbiology.
- A track record of success in publication of findings in peer-reviewed journals is desired.
- Ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required.
- Ability to evaluate technical data and write technical documents.
- Excellent interpersonal, leadership, coaching, and conflict resolution skills.
- Proficient in standard computer applications, with excellent skills in Excel, Word and PowerPoint.
- Must be able to obtain, manipulate and analyze data and effectively collate and present information into reports or presentations.
- Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints
- Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization
- Strong work ethic and an ability to excel within a rapidly changing and growing organization
About Ventura Solutions:
Ventura Solutions is a rapidly growing medical device and pharmaceutical staffing, consulting, and training firm. Our extensive industry expertise in medical device, pharmaceutical, and combination products along with an exceptional talent pipeline make us a top choice for a wide range of projects. We also offer great benefits which enable us to attract and retain top talent in the medical device, pharmaceutical, and combination products space. For more information and other job opportunities visit us at ventura-solutions.com
Equal Opportunity Employer Minorities/Women/Veterans/Disabled