Sr. QC Biochemical Operations
: Job Details :

**Sr. QC Biochemical Operations**Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .About Astellas Gene TherapiesAstellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com.The RoleAstellas Gene Therapies is seeking an experienced Senior Analyst to join the Quality Control Biochemical Operations group. The Senior Analyst will be responsible for implementing and executing analytical testing in support of clinical and commercial products in compliance with GMP requirements. The Senior Analyst will also support testing for stability studies, methods validation/qualification, method transfer studies and equipment validation.Responsibilities+ Perform release, stability, and in-process testing in supporting production activities+ Author/revise technical reports and laboratory procedures (SOPs and methods)+ Perform analytical testing in supporting method transfer/validations+ Review/authorize data and performs analysis and interpretation of test results+ Participate in method development; equipment qualification/validation studies; deviation and OOS investigations; troubleshoot methods, as needed+ Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration+ Participates in QC inspections and audits as necessary+ Assists in the preparation and review of CMC regulatory submissions as needed+ Support and mentor junior team members+ Other duties as requiredQuantitative Dimensions:+ The Senior Analyst, Quality Control Biochemical Operations is responsible for implementing and executing analytical testing, support testing for stability studies, methods/validation/qualification, method transfer studies, and equipment validation.Required Qualifications+ B.S. degree in Biological Sciences with 5+ years of relevant industry experience or M.S. degree in Biological Sciences with 3+ years of relevant industry experience in a quality control role+ Prior experience in GMP QC environment (minimum 1 year) and strong understanding of data integrity requirements and regulatory requirements pertaining to biotechnology and pharmaceutical industries+ Demonstrated experience in molecular/cell biology required (minimum 1 year)+ Prior laboratory hands-on experience with a variety of analytical techniques including, but not limited to ddPCR, nucleic acid purification/detection, protein quantification, ELISA, and gel electrophoresis+ Proven experience analyzing experimental data+ Excellent technical writing skills+ Must be capable of observing and adhering to lab safety standards and procedures+ Successfully performs routine work independently with minimal instructions+ Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion+ Strong interpersonal skills, highly collaborative within a multi-disciplinary team and contributes to a supportive and positive work environment+ Highly self-motivated and goal-oriented+ This role is scheduled to work during normal business hours, typically starting at 8:00 AM, Monday - Friday+ Flexibility to cover off-shift work may be required+ Will support and demonstrate quality standards to ensure data of highest quality+ Works closely with team and other functional key stakeholders on the Astellas AGT Technical Operations team to execute work and will be expected to perform other duties and/or special projects as assignedPreferred Qualifications+ Background in biochemistry or virology+ Demonstrated experience with mammalian cell culture and cell-based assays+ Prior experience working with LIMSWorking Conditions+ This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs+ This is an on-site role working in a cGMP regulated manufacturing facility+ On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%)Benefits:+ Medical, Dental and Vision Insurance+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks+ 401(k) match and annual company contribution+ Company paid life insurance+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions+ Long Term Incentive Plan for eligible positions+ Referral bonus programAll qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.\#LI-TR1Category Sanford TCAstellas is committed to equality of opportunity in all aspects of employment.EOE including Disability/Protected Veterans