Senior Scientist, Engineering- Analytical Container Closure Integrity (CCI)

Biopharma Careers; West Point (MS); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Job summary

Biopharma Careers seeks a Sr. Scientist/Engineer to focus on CCI analytical work for packaging and device programs in late-stage development and manufacturing support.

You will contribute to method development, validation, transfers, and cross-functional collaboration with technical teams. Required BS/MS/PhD in engineering or physical sciences with 5+ years in pharma/biotech/medical devices; familiarity with CCI testing and standards (USP, ISO-13485) is expected.

Qualifications

• BS/MS with minimum of 5 years or relevant experience in the pharmaceutical, biotechnology, or medical device industries or PhD.
• Familiarity and some experience with CCI testing in either an industrial or academic context.
• Preferred experience: CCI technologies and testing methods, and understanding of USP, ISO-13485 standards.

Responsibilities

• Characterize new package or device components to inform selection or optimization.
• Develop and validate CCI methods.
• Transfer methods and lifecycle support.
• Provide in-depth technical support for packaging and device CCI investigations.
• Grow CCI analytical technologies within the CPDA.

Skills

Analytical Dev

Analytical Thinking

Biomedical Eng

Biotechnology

Chemical Eng

Chemistry

Combination Products

Container Closure Integrity

Materials Science

Medical Devices

Method Development

Package Testing

Pharmaceutical Industry

Education

Engineering degree (Mechanical/Chemical/Biomedical)

Job description

The Center for Packaging & Device Analytics (CPDA), within our Manufacturing Division, is responsible for physical, analytical & material science to support production and commercialization of product packaging and drug-delivery medical device/combination-products (MDCPs), such as auto-injectors and pre-filled syringes. We are an interdisciplinary engineering science Center of Excellence that supports the entire global-human-health portfolio and closely partner with various Packaging or Device Technology engineering groups, packaging sites, and partner analytical groups. The CPDA is located at our Company’s large research and manufacturing West Point, PA location, where our packaging & device laboratories are established.

Container closure integrity (CCI) is a critical quality & performance attribute across sterile packaging and components, such as vials, pouches, syringes, cartridges or bulk containers.

The CPDA is seeking a Sr. Scientist/Engineer who, as an individual contributor, would enjoy focusing on CCI analytical and technical contributions to our packaging and medical device-combination product programs in both late-stage development and supporting global manufacturing. Projects are diverse and typically include some of the following: (1) characterization of new package or device components to inform selection or optimization; (2) CCI method development & validation; (3) method transfers/lifecycle support; (4) in-depth technical support to resolve packaging and device CCI analytical and manufacturing investigations; and, (5) growing CCI analytical technologies/ capabilities within the CPDA. To excel in the role, one must be creative and skillful in problem solving and applied experimental physical science, be a highly effective communicator (written and verbal) & collaborator on cross functional teams, and, have interest in both long‑term strategic technology advancement and personal growth.

Required Education, Experience, and Skills:

Education Requirement (minimum):

BS, MS or PhD in Mechanical, Chemical or Biomedical Engineering or associated scientific discipline, such as physical chemistry.

Required Experience:

BS/MS with minimum of 5 years or relevant experience in the pharmaceutical, biotechnology, or medical device industries or PhD.

Familiarity and some experience with CCI testing in either an industrial or academic context.

Preferred Experience and Skills:

• Advanced proficiency and understanding of all common CCI technologies, such as dye ingress, high voltage leak detection, vacuum and pressure decay, laser headspace, and tracer gas analysis.
• Hands-on CCI test method development, validation, and troubleshooting for packaging and/or medical device products.
• Understanding/familiarity with USP , ISO-13485, and relevant industry standards.

Required Skills:

Analytical Method Development, Analytical Thinking, Biomedical Engineering, Biotechnology, Chemical Engineering, Chemistry, Combination Products, Container Closure Integrity Testing (CCIT), Materials Science, Medical Devices, Method Development, Package Testing, Pharmaceutical Industry

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

The salary range for this role is

$117,000.00 - $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Employee Status: Regular

Relocation: Domestic

VISA Sponsorship: Yes

Travel Requirements: 10%

Flexible Work Arrangements: Not Applicable

Shift: 1st - Day

Valid Driving License: No

Hazardous Material(s): n/a