Job Title: Process Development Associate Location: Thousand Oaks, CA, 91320 (ONSITE) Duration: 12 months Schedule - 8-5pm
Experience: Open to a recent graduate with basic lab experience
Nice to have: Cell culture, PCR, biological assays, work with bioreactors and/or AKTA chromatography, and data analytics and visualization knowledge.
Job Summary: The Product Quality Director is the champion for a product team as the Product Quality Leader (referred to as PQL), providing technical expertise, strategic and project leadership to the Product Quality (PQ) organization. The PQL has responsibility for working with PQ staff and executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory, Process Development, Quality Assurance, and other functional areas on the resolution of issues associated with process/manufacturing, in process controls, analytical methods, specifications, reference standards, importation testing, investigations, change control, regulatory submissions and inspections.
Preferred Qualifications:
Advanced degree in chemistry, biochemistry, biology, or a related biotechnology sciences field? Expertise in the areas of protein and small molecule analysis and industry regulations
8+ years of pharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience? 6+ years working in a regulated environment (direct GMP)
5+ years managing staff with increasing responsibilities and larger groups
2+ years experience as a technical expert or product champion? 1+ years of experience with authoring or review of regulatory filing or similar regulatory documentation.
1+ years of experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
Experience in Project Management in support of product development? Knowledge of protein and small molecule quality, compliance and regulatory requirements
Knowledge of analytical techniques used for protein molecule product quality control? Understanding of drug substance and drug product development and manufacturing
Strong leadership and management skills? General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals
Top 3 Must Have Skill Sets: 1. Hands-on experience in a wet lab. 2. Culturing microbial or mammalian cells and/or purifying proteins through chromatography. 2. Design experiments to investigate scientific or engineering questions.
Day to Day Responsibilities: 1. Design and execute experiments at the bench scale in the lab. 2. Record experiment methods and data in electronic notebooks. Analyze and communicate data through report writing and presentations. 3. Contribute to technology development, including process automation.
Possible Extension: Yes Red Flags: Long length of absence between work experiences. GPA below 3.00. Not looking for a Ph.D. or too much job history.
Interview Process: A phone interview followed by a panel interview.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $27.64/hr.
