Director of Laboratory Operations
Location: San Diego, CA
Eurofins Advantar Laboratories, Inc is searching for Director of Laboratory Operations in San Diego, CA.
Director responsibilities include, but are not limited to, the following:
- Responsible for directing and providing scientific and technical leadership for overall research and development activities in support of customer driven product development projects
- As a Study Director, you will serve as the principal customer facing contact coordinating all communications and project deliverables with accountability for achieving agreed upon project and revenue milestones
- Lead development, qualification and validation of analytical test methods for drug product, intermediates, and excipients for clients
- Understand enough about Preformulation and Formulation principles to conceptualize approach and develop bench scale formulations to overcome stability and/or solubility limitations
- Accountable as the final reviewer for scientific rigor, conclusions and quality of reports sent to customers
- Lead team, schedule, and train employees in client environment
- Ensure adherence to highest quality and efficiency standards in laboratory operations
- Ensure coverage and performance
- Foster morale and teamwork
The ideal candidate would possess:
- Extensive knowledge of the pharmaceutical product development process and FDA regulatory requirements for IND's and NDA's CMC sections
- Direct experience interfacing with FDA
- Extensive experience with variety of analytical techniques and method development and validation
- Knowledge of Water's Empower software desirable
- Experience in designing experiments, stability programs, data analysis and interpretation
- Must have excellent record keeping skills, be detailed oriented and have outstanding organization skills
- Ability to work under aggressive timelines with multiple task assignments
- Experience in a contract lab or fee-for-service business is preferred
- Flexible working style with ability to rapidly adjust to changing project priorities
- Experience in supervising and leading junior level scientists with a keen interest in mentoring and developing ones staff members.
- Strong computer, scientific, and organizational skills
- Excellent communication (oral and written) and attention to detail
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
- Strong leadership, initiative, and teambuilding skills
Basic Minimum Qualifications:
- PhD in a Chemistry discipline, Pharmaceutical Sciences or related field
- At least 10 years of relevant experience
- Hands-on GXP experience required
- Must have HPLC experience
- Authorization to work in the United States indefinitely without restriction or sponsorship
Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed. Candidates currently living within a commutable distance of San Diego, CA are encouraged to apply.
Eurofins is the world leader in the food, bio/pharmaceutical product testing. It is also number one in the field of environmental laboratory services and one of the global market leaders in agroscience, genomics, discovery pharmacology, and central laboratory services. With over $2 billion in annual revenues and 25,000 employees across 250 sites in 39 countries, Eurofins is a leading international group of laboratories providing an unparalleled range of testing and support services to the pharmaceutical, biopharmaceutical, food, environmental, and consumer products industries and to governments.
Eurofins Advantar Laboratories, Inc provides expertise in virtually all dosage forms including small molecule, peptide, protein, DNA, RNA and oligonucleotide drug molecules. Our GMP-compliant services include pre-formulation and formulation development, analytical methods development/validation/remediation, release and stability testing, compendial analysis, and clinical trial material labeling and packaging.
As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k), paid holidays and vacation, personal days, and dental and vision options.
To learn more about Eurofins, please explore our website www.eurofinsus.com.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.