Principal Analyst, QC Compliance, Operations

Why Work for Us

Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.

About Astellas Gene Therapies

Astellas Gene Therapies is 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 the 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.audentestx.com .

Our Values:

• Be BOLD (Find a Way)

• Care Deeply -- for our patients, each other and our work

• #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

We are looking for a self-motivated candidate to join the Operations Group within the Quality Control Department. The Senior Analyst/Principal Analyst, QC Compliance, Operations, who will report to the Manager, QC Operations, will be responsible for compliance of the laboratory operations to internal procedures and regulatory standards ensuring inspection and commercial readiness of the QC operations. Must have demonstrated track record of ability and initiative to work independently and in a collaborative team-oriented setting in line with the vision/mission of the core group. The position will be in our offices in South San Francisco, CA.

Areas of responsibility , include but are not limited to :

• The validation of computerized systems, qualification and maintenance of equipment, and management of quality records;

• All aspects of the role will require active management of the integrity of data.

• Improvement and optimization of laboratory operations including training program to provide a robust and scale-able process that is compliant and efficient will be an area responsibility

Primary Responsibilities

• Ensure data integrity principles are applied across the organization including identification of gaps and resolution.

• Ensure the performance and process of Quality Control to assure that product and process meet company and regulatory requirements

• Identify QC compliance gaps and improvements towards resolution for successful inspectional and audit outcomes.

• Participate and represent the QC organization in regulatory inspections and internal audits including interfacing with inspectors, as needed.

• Responsible the qualification and maintenance including scheduling of equipment to ensure laboratory operations are maintained with minimal interruptions to business needs.

• Responsible for the validation of computerized software or tools within Quality Control in accordance with industry standards, regulatory expectations, and data integrity while assuring business needs are met for the intended use.

• Manage the quality records (e.g. laboratory investigations, deviations, change controls, and CAPAs) for Quality Control ensuring on time closure, escalation of issues, and root-cause analysis to identify root cause and improvements.

About you

Must Have/Required

• Education Minimum Required: BS in Biochemistry, Chemistry or related Sciences Preferred: MS in related fields

• Experience Minimum Required: 8+ years in a GMP environment (pharmaceutical or biotechnology industry) with at least 2 of those years in QC leadership roles

• Knowledge, Skills and Abilities Minimum Required: Proven strong interpersonal, organization and problem-solving skills

• Solid knowledge and understanding of US and international (e.g. EU, ICH, GXP) regulations and guidance applicable to Quality Control and method validation

• Experience with technical writing and regulatory requirements for investigative writing as well as quality records.

• Familiar with regulatory guidance's and requirements (e.g. ICH, USP, WHO, GAMP, etc.) including data integrity Experience in preparing for and participating in regulatory inspections and audits.

• Experience in identifying issues, driving changes and improvements, and streamlining process.

• Effective verbal and written communications skills, detail-orientated with the ability to work effectively in a fast paced, multi-disciplinary team environment

• Preferred: Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines

• Experience with developing and implementation of QC testing programs for biologics drug substance and injectable drug product in a commercial environment

• Experience with preparing regulatory documentation and inspection management

• Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

• 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 program

Category Quality Control

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans