Job Description
The Position
This position is part of the Hillsboro Innovative Therapies (HIT) Analytical Development and Quality Control (ADQC) team responsible for supporting the development of new modalities in the Pharma Technical Cell and Gene Therapy (PTC) organization, the position based in Hillsboro, Oregon. PTC focuses on the development of cell and gene therapeutics (CGT) for the treatment or cure of various diseases. In this role, you will perform Environmental Monitoring (EM) and critical utility monitoring activities in support of the clinical manufacturing of CGT.
The Position is located in Hillsboro, Oregon, On-site (occasional need to work overtime and on weekends)
The Opportunity
Responsibilities include sample collection, evaluation and data reporting, and coordination of required excursion response and restart activities. Additional responsibilities include managing consumables and maintaining equipment.
Execute non-viable air, viable air, surface, and critical utility sample collection in a cleanroom and/or unclassified environment with documentation according to cGMP
Partner closely with Quality Assurance to ensure the Environment and Utility Monitoring programs are in compliance with internal standards and regulations
Use SOPs in full compliance with cGMP regulations and evolving expectations
Develop new business processes to constantly improve ourselves
Identify gaps, technical problems, deviations and discrepancies
Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
Receive and provide training
Support the maintenance and compliance of operational areas
Work to meet schedules, timelines, deadlines
Perform any other tasks as requested by Management to support site and analytical activities.
Who you are:
You possess a B.S./B.A. Degree and two years of experience or Master’s degree plus one year experience or an equivalent combination of education and experience. Degrees are preferably in Microbiology, Biochemistry, Molecular Biology or relevant scientific discipline and experience is in pharmaceutical or biopharmaceutical industry.
You have experience performing Environmental Monitoring (EM) and knowledge of cGMP regulations.
You possess demonstrated ability to work independently to accomplish tasks
You have strong verbal and written communication skills, ability to organize and present information both formally and informally
You are able to follow Quality standards
You possess flexibility in problem-solving and work hours to meet business objectives.
Work Environment/Physical Demands/Safety Considerations:
Work in a clean room environment.
Prolonged periods of standing/sitting.
Frequent lifting (up to 25 lbs), bending, reaching, twisting.
Relocation benefits are not available for this job posting.
The expected salary range for this position based on the primary location of Oregon is $52,600- $78,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.