Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
Key responsibilities:
Provide oversight and leadership to one or more commercial stability programs.
Work in collaboration with Technical Product Teams, Global Regulatory Sciences, and manufacturing sites to develop stability product requirements for annual enrollments, process changes and investigations. Determine the stability requirements for each commercial product based on technical rationale and globally approved dossiers. Maintain a list of required yearly stability enrollments. Provide testing projections to the QC laboratories.
Manage the stability book of work and ensure that stability activities are completed per site and brand timelines.
Perform change control impact assessments and document the stability assessment in change controls. Review and endorse change controls as an expanded reviewer. Initiate change controls related to stability operations or product shelf life extension.
Provide the technical requirements in a Master stability protocol, review and approve study specific protocols or batch enrollment forms. As needed, review and activate LIMS stability studies.
Represent GBS on laboratory and manufacturing investigation teams. Perform stability impact assessments as required.
Support stability evaluations by reviewing OOT assessments and process robustness presentations
Support stability data reporting by authoring or reviewing Health Authority submissions and responding to Health Authority Queries. Point person for global rollout of observations that may affect stability programs and develop strategies to close gaps/mitigation.
Approve, identify, write and revise stability procedures. Assist with development of company-wide Stability directives.
Act, escalate, identify information regarding stability program that may impact lab capacity, product studies or regulatory commitments directly and promptly to management
Identify and devise training need for ongoing stability activities. Ensure training requirements are met.
Works according to cGMP requirements and HA expectations.
Represent global stability in Health Authority inspections and internal quality audits
Participate and/or lead OpEx initiatives to streamline and standardize management of stability programs.
Education and Experience:
Bachelor's degree in lab sciences such as biology, biochemistry, immunology, chemistry, molecular biology or similar
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years') or equivalent combination of education, training, & experience.
OR Master's degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 10+ years)
OR PhD (preferred) and previous experience that provides the knowledge, skills, and abilities to perform comparable to PhD plus 8+ years of work experience)
Previous experience that provides the knowledge, skills, and abilities to perform the job
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Expert knowledge and understanding of ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a biologics manufacturing facility.
Excellent written and verbal communication skills in presenting stability strategy to technical teams and in change control and investigations management system. Ability to work collaboratively in a team matrix environment is required.
Significant experience with evaluating and interpreting stability data using statistics and statistics software.
Expert knowledge and good understanding of analytical and/ or Microbiology techniques including advanced assays in the fields of Cell Based Bioassay, Immunoassay, Separation technology (chromatography)/ Bioburden/ Endotoxin
Exhibit strong leadership and decision making skills especially in problem solving and analytical thinking.
Significant experience in Operational Excellence, with proven record of accomplishment in continuous improvement. Prior experience with commercial stability trouble-shooting and demonstrated expertise in Biologics or Protein Therapeutic molecule
Significant front room FDA/Inspectional experience on stability programs
Working Environment:
Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with
proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
