Position OverviewWe are looking for a scientist with experience with raw materials and specific primary packaging for drug product manufacturing. We are looking for a structured, pragmatic and diplomatic person that can support the drug product area within QC Raw Materials. You will be working closely with the small team handling materials to enable the readiness of the drug product facility. Additionally, you will be involved in tech transfers for new customers and their products at FUJIFILM Biotechnologies.
Job DescriptionWhat You'll Do- Authoring testing strategies, specification justifications and corresponding specifications for primary packaging materials, disposables and raw materials used in the DP manufacturing processes and any devices to be used together with the product.
- Writing and updating SOPs within the DS and DP material area.
- Representing QC Raw Materials in Tech Transfer projects, including customer interactions.
- Focus on continuous improvements to all our processes and challenge status quo.
- Performs other duties as assigned.
Knowledge, Skills, or Abilities- Displays an advanced knowledge of regulatory requirements for materials (e.g., cGMPs, USP, EP, JP, and ICH).
- Possesses a broad knowledge of quality control operations, systems, and directives.
- Ability to challenge and interpret regulations with scientific confidence and sound risk-based judgement.
- Demonstrates excellent technical writing skills, and clear oral and written presentation abilities.
- Strong stakeholder management and communication skills, enabling alignment across sites and global functions.
Minimum Qualifications- Master's degree in Life Sciences or Engineering and 4+ years of experience in GMP quality assurance and/or similar role.
- 5+ years of experience within the pharmaceutical industry, preferably within the field of starting materials and primary packaging.
Preferred Qualifications- Preferable experience from similar role.
- 2+ years of experience with customer meetings and audit/inspections.
- 5+ years of experience in a GMP environment.
- Experience with Microsoft Office, Smartsheet, LIMS and ERP systems (e.g., SAP).
Physical Requirements:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:
- May work in Mechanical/Production spaces that may require hearing protection and enrollment in hearing conservation program.
- Ability to stand for prolonged periods up to 60 minutes.
- Ability to sit for prolonged periods up to 30 minutes.
- Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
*LI-Onsite
