About CooperSurgical
JOB DESCRIPTION
CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.
CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com .
Responsibilities
Job Summary:
This is a high visibility and high impact technical leadership position responsible for CopperSurgical’s In vitro fertilization (IVF) Media product line ― specialized solutions used to support the growth and development of embryos outside the human body during the IVF process.
As the R&D biochemistry lead you will be involved in all aspects of Media product portfolio support including methods development, line extension, product improvements, business continuity as well as technical support for new markets registrations. This is the technical leadership position that is expected to have strong communication skills in order to drive an effective cross-functional collaboration with Manufacturing, Regulatory, Quality, Medical Affairs and Commercial functions.
The Life Sciences team provides a setting for R&D professionals to be involved in cutting edge scientific advances via product development and engineering projects that have a real impact on patients utilizing CooperSurgical products and services. This role operates in a dynamic environment, and it is expected to manage multiple complex tasks while ensuring technical rigor and functional excellence. Our Sr. Staff Scientists are subject matter experts and technical leaders who are embracing full ownership of complex R&D activities and cross-functional collaborations to meet CooperSurgical’s business objectives and future growth aspirations in the Life Sciences product portfolio.
This position reports to the Director, Life Sciences R&D and it is based in Houston, TX or Livingston, NJ.
Essential Functions & Responsibilities:
- Responsible for product evaluations, test methods development and product validation activities associated with IVF Media product development, improvements and changes.
- Provide biological assessments and risk mitigation support to manufacturing plant(s) in support of process development, maintenance and improvements.
- Program, project and/or task management of R&D workstreams associated with IVF Media related initiatives.
- Providing adequate documentation and technical inputs in support to regulatory and commercial business continuity and growth opportunities.
- Full ownership of functional excellence by driving technical rigor, process discipline and timely execution in compliance with all applicable policies and best practice guidelines.
- Aid and drive an effective cross-functional collaboration ensuring timely and efficient delivery of target business outcomes.
- Drive and/or oversee definition of design inputs (i.e., product requirements) and technical strategies for an adequate verification and validation approach associated with IVF Media products.
- Present to the senior and executive leadership.
- Manage collaboration and relationships with external partners, consulting firms and vendors.
- Drive medical devices design control compliance by ensuring that all applicable safety, quality and regulatory guidelines and policies are followed to develop safe and effective products.
Travel:
- Occasional (:10%) travel.
Work Environment:
- Mainly office in combination with limited laboratory and occasional manufacturing work environment
- At times will entail prolonged sitting in front of a computer.
- Willingness to adjust work schedule to meet the demands of the company including occasional non-business-hours.
Qualifications
Qualifications, Knowledge, Skills and Abilities:
- Hands-on experience with life science laboratory techniques and best practices is required
- Proficiency with biochemical and statistical methods associated with design of experiments and analytical methods is required
- Track record and experience relating to IVF Media products is preferred and will provide advantage
- Knowledge with MDR/MDD regulations and experience with ISO 10993 is strongly desirable
- Working knowledge of domestic and international regulations relating Class II and III Medical Devices is required
- Problem-solving, structured, risk-based and systematic approach
- Track record of project management activities is strongly desirable
- An outcome focused mindset including process discipline and drive for timely project completion.
- Excellent interpersonal and effective communication skills with internal and external stakeholders ranging from project engineers and consultants to key opinion leaders and executives.
Experience:
- 10+ years of relevant experience, depending on degree level, in product development, product engineering or relevant field within Medical Devices/Pharmaceutical Industry. Preferably in a scientist or engineering role.
- Experience in IVF Media or cell culture media products development & manufacturing is highly desirable
Education:
- Minimum life science and/or clinical education background (B.A. or B.S).
- Preferred, advanced graduate degree (PhD) in relevant scientific field such as Biochemistry, analytical chemistry OR a Masters degree in similar field with 4-7 years of experience.
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $XX,000 - $XXX,000. The actual base pay includes many factors, and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.
