Technology Transfer Specialist I/II/Sr.

Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.

Our Promise: Caring, Sharing, Growing

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.

Job Description:

The position of Manufacturing Science and Technology - Technology Transfer Specialist I/II/Senior has responsibility for one or more of the following areas within MS&T: technical transfer of new products from both internal and external clients; manufacturing support for process and material investigations or media fill program coordination. The Specialist II performs tasks within these areas, without direct supervisory responsibilities.

1. Evaluate incoming processes for robustness, efficiency and fit within JHS-Spokane. Perform appropriate development work to define CPPs and CQAs to allow strong execution upon transfer to Manufacturing. Author validation study documents that demonstrate manufacturing processes are capable of consistently making acceptable product.
2. Represent MS&T on Project Teams for internal and external projects.
3. Perform investigations for process and material deviations, driving to root cause. Implement effective CAPAs designed to empower flawless execution.
4. Provide support to all departments associated with manufacturing processes: Manufacturing, Technical Writing and Microbiological Quality Control (MQC).
5. Ensure that all applicable U.S. and European regulatory requirements are being met within MS&T owned procedures and practices.
6. Review data summaries generated by other departments, assess the data for potential trends or conditions that may adversely impact the quality of the sterile products being manufactured, and ensure that corrective action measures are implemented when required/warranted.
7. Provide necessary summaries and reviews for regulatory and customer inspectors/auditors; provide responses to written observations made by the inspector/auditors, and ensure that all corrective action measures are completed as described and within the time-frame given in the response.
8. Review assigned Standard Operating Procedures (SOP's), Protocols and Acceptance Reports from the perspective of scientific soundness and compliance with applicable regulatory requirements, and provide input/changes as needed.
9. Ensure that investigations related to deviations are complete and adequate.
10. Specialist II - Advise other Specialists within Technology Transfer, Manufacturing Support or Media Fills.
11. Senior Specialist - Mentor Specialists within Technology Transfer, Manufacturing Support or Media Fills.

Qualifications:

• A Bachelor's of Arts and Science with a major in Biology, Chemistry, Physics, or Engineering is required, a Master's Degree is desired. A Master's Degree counts as 2 years of experience for these positions.
• Specialist I - Pharmaceutical experience and FDA regulated industry experience is desired.
• Specialist II - Minimum of 2 to 5 years of combined experience within pharmaceutical and/or FDA regulated industry experience.
• Senior Specialist - Minimum of 5 to 10 years of combined experience within pharmaceutical and/or FDA regulated industry experience.
• Proficiency in Microsoft Word, Excel and PowerPoint required.
• Physical Requirements: Prolonged sitting. Ability to work in clean-room environment required. Minimal travel required.

Shift: Day

Compensation:

• Specialist I: The salary range for this position is $67,725 - $83,700 depending on experience.
• Specialist II: The salary range for this position is $67,725 - $98,500 depending on experience.
• Senior Specialist: The salary range for this position is $70,000 - $115,800 depending on experience.
  

Benefits:

• Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
• Life, AD&D, Short and Long Term Disability
• 401(k) with company match
• Generous paid time off plan
• Employee Assistance Program
  

Optional Benefits:

• Voluntary Life and AD&D for employee & family
• Supplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages)
• Pet Insurance
• ID Theft Protection
• Perk Spot Discount Program

Jubilant HollisterStier is a great place to grow!
If you're up for a rewarding challenge, we invite you to take the first step and apply today!

https://www.jublhs.com/careers/career-opportunities
*Please click on the Spokane, WA link*

Jubilant HollisterStier is an EEO/AA Employer.

All qualified applicants will receive consideration for employment without regard to their protected veteran status and will not be discriminated against on the basis of disability.

If you require assistance applying for a position, please contact our HR Department at:

HResources@jhs.jubl.com