From BioAgilytix's posting. “We” and “our” refer to the employer.
At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly.
You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.
The Manager I will lead scientific and operational activities in support of preclinical, clinical, and product release studies for our San Diego lab. This role requires deep expertise in developing chromatographic assays for a variety of modalities in complex biological matrices using HPLC and LC/MS/MS. The ideal candidate will have hands-on and leadership experience overseeing regulated bioanalysis, tissue analysis, protein binding, CYP inhibition/induction, CYP phenotyping, and metabolite profiling/ID.
You’ll guide a team of scientists through assay development, validation, and sample analysis under GxP, while also playing a key role in client engagement, project delivery, and cross-functional collaboration.
Essential Responsibilities: Lead team(s) developing and validating bioanalytical assays for support of preclinical, clinical and product release studies.
Motivating team by inspiring employees to achieve goals and aligning employee goals with company strategy by understanding trends and operations, managing departmental budgets and resources, and being the expert in using tools/software relevant to the team.
Work closely with clients to assure successful on time execution of assays, validation, and sample analysis under GxPs.
Prioritizing tasks and managing schedules efficiently.
Meet regularly with lab management to ensure instrument resources and employees are utilized effectively across all teams.
Responsible for team performance and outcomes.
Leading teams through transitions and new initiatives.
Design and execute experiments efficiently and assign tasks appropriately to employees based on skills.
Anticipating and mitigating potential problems and handling disputes calmly and fairly
Present data and posters.
Conduct group team meetings to understand employee’s input and concerns, give constructive and timely feedback, and implement 1:1 meetings with employees on a regular basis.
Hiring and building a team that is knowledgeable and cooperative by investing in the employees’ professional growth, setting goals and evaluating results.
Identify new analytical techniques and technologies and lead their implementation.
Review analytical instrument and equipment calibration, qualification and maintenance records.
Perform statistical analysis.
Write and review reports and prepare SOPs.
Fulfill the role of Bioanalytical Project Manager (BPM)/Principal Investigator (PI) for all assigned clients and studies.
Lead regularly scheduled client meetings to ensure effective communication and manage client expectations.
Provide client satisfaction and great science.
Achieve corporate revenue targets.
Additional Responsibilities: Other duties as needed
Minimum Preferred Qualifications: Education/Experience: Bachelor’s degree in molecular biology, biochemistry, chemistry, immunology, biotechnology, or related field with not less than ten (10) years’ experience in a scientific laboratory environment; or
Master’s degree in molecular biology, biochemistry, chemistry, immunology, biotechnology, or related field with not less than eight (8) years’ experience in a scientific laboratory environment; or
PhD in molecular biology, biochemistry, chemistry, immunology, biotechnology, or related field with no less than six (6) years’ experience in a scientific laboratory environment
Minimum Preferred Qualifications: Skills: Ability to develop chromatographic assays for all modalities in complex biological matrices using HPLC or LC/MS/MS and oversee the following study types: regulated bioanalysis, tissue analysis, protein binding, CYP inhibition, CYP induction, CYP phenotyping or metabolite profiling/ID
Write and execute validation and sample analysis plans
Review and evaluate PK/TK data and ISR results to identify trends and outliers
Plan and execute cross-site validations for projects transferring between sites
Must work effectively within team to meet objectives under time constraints
Ability to make sound judgments quickly and confidently
Ability to take direction well and multi-task
Detail oriented and highly organized
Excellent oral skills, communicating clearly in meetings or presentations.
Excellent written communication skills, writing clear reports, emails, or policies
Proficient in the use of MS Excel and Word
Demonstrated experience serving in a supervisor role and leading teams
Knowledge and application of regulatory guidance to experimental planning and design
Experience working in GxP environments and demonstrated knowledge of GxP regulations
Supervisory Responsibility: This position supervises Analyst I/II/III & Scientist I/II/III
Ability to guide and direct others in successful outcomes and provide mentorship
Performance reviews/evaluations and career development of staff
Supervision Received: Infrequent supervision and instructions
Frequently exercises discretionary authority
Working Environment: Primarily laboratory environment
Exposure to biological fluids with potential exposure to infectious organisms
Rare exposure to skin and lung irritants, toxic materials, and hazardous waste
Personal protective equipment required, such as protective eyewear, garments, and gloves
Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
Physical Demands: Ability to work in an upright and/or stationary position for up to eight (8) hours per day
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment
Frequent mobility needed
Frequent crouching, stooping, with frequent bending and twisting of upper body and neck
Light to moderate lifting and carrying (or otherwise moves) objects, including laboratory equipment, laboratory supplies, and laptop computer, with a maximum lift of 20 pounds
Ability to access and use a variety of computer software
Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
Frequently interacts with others to obtain or relate information to diverse groups
Requires multiple periods of intense concentration
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
Ability to perform under stress and multi-task
Regular and consistent attendance
Position Type and Expected Hours of Work: This is a full-time position
Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
Occasional weekend, holiday, and evening work required
BENEFITS AND OTHER PERKS
Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (9 scheduled; 5 floating), 401k with Employer Match, Employee Referral Program
COMMITMENT TO EQUAL OPPORTUNITY
BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.
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