What are the responsibilities and job description for the Manager, Quality Control Microbiology position at Denali Therapeutics Inc?
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
Responsibilities (include but are not limited to the following)
- Management of the Microbiology Laboratory and microbiological testing
- Drive qualification, implementation and execution of micro USP methods for biological product – includes in-process, release and stability
- Support microbiology quality events
- Author and/or review microbiology procedures that also include protocols and reports
- Manage sample submission to third party for microbial identification
- Manage and develop microbiology personnel and work closely with warehouse, manufacturing and quality assurance
- Implement and manage streamline microbiology operations for the facility
- Work closely with quality on defining and implementing aseptic techniques and cross contamination controls
- Undertake facility environmental trend reporting
- Represent facility as Microbiology subject matter expert
- Work with accuracy, urgency and a continuous improvement perspective
Requirements
- BS in Biology or Microbiology
- 7 years of experience in Pharmaceutical or Biotech Microbiology
- Familiarity with USP test method qualifications and execution
- Familiarity with Environmental Monitoring
- Knowledge of current USP/Ph. Eur./FDA/ISO/GMP standards and guidance
- Ability to work with independently
- Well developed verbal and written communication skills
- Ability to closely follow quality standards and have attention to detail
- Strong collaboration skills
- Excellence in execution through accuracy, right first time and a proactive nature
- Ability to learn quickly, driven by high curiosity
- Physical requirements– must be able to put on specialized gowning, lift and manipulate items over 25 lbs, climb ladders, stand for multiple hours at a time
Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
