Analytical Chemistry Manager - Santa Rosa, CA, CA | Biospace
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Analytical Chemistry Manager

Medtronic

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Location:
Santa Rosa, CA, CA
Posted Date:
3/20/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biochemistry, Chemistry, Laboratory, Manager,

Job Description

The Chemistry manager manages a team of chemists who are responsible to provide compliant (GLP and cGMP) analytical chemistry support for the organization.  Additionally, the team is also responsible to support early research and product evaluation.  He or she works collaboratively with the technical services group to meet the groups testing demands, data reporting timelines. The Chemistry Manager provides scientific direction, recommendations, and solutions for testing, test method development and validation, as well as laboratory quality systems. She or he works closely with the quality steward on validations, compliance, and quality.
The position may require direct coordination of analytical testing and research activities within the STAC/CIS organization.  The individual provides technical expertise to drug combination development teams.  The analytical activities include but are not limited to the testing of incoming raw materials, active drug substances, in-process samples, finished products, stability samples, biological samples, samples of unknown composition
The position may require direct coordination of analytical testing and research activities within the STAC organization.  The individual provides technical expertise to drug combination development teams.  The analytical activities include but are not limited to the testing of incoming raw materials, active drug substances, in-process samples, finished products, stability samples, biological samples, samples of unknown composition.



MAIN JOB DUTIES/RESPONSIBILITIES:
Lead by example with a high level of compliance with regard to cGMP regulations, 21 CFR Part 04/ 210/211/820 and other applicable guidelines if required
Lead by example with a high level of compliance with regard to GLP regulations, 21 CFR Part 58 and other applicable guidelines as required
Participates with other Managers and Directors within CardioVascular Integrative Sciences in establishing strategic plans and objectives.
Manages the coordination of activities with responsibility for results in terms of costs, methods and employees
Works with the CIS leadership and R&D engineering leaders on cost forecasting
Ensures adequate laboratory support to meet ongoing product test requirements.
Provides leadership to the chemistry staff regarding development of individuals’ goals and mentoring of the group.
Interviews, hires, and actively participates in the development of direct reports.
Reviews performance of direct reports with consideration toward established goals, department performance / metrics, and divisional performance / metrics.
Works on problems of diverse scope where analysis of a situation or data requires evaluation of multiple factors.
Develops and Implements systems to ensure the laboratories are in compliance with applicable regulations, e.g. cGMP and GLPs.
Ensures the procurement and maintenance of suitable instrumentation to measure and evaluate chemistry related aspects of drug combination products.
Ensures communication within the CV development teams regarding any laboratory related quality problems; drives closure of the problem and implementation of remedial and corrective actions.
Drives continuous improvements to the test methods and related documentation used to evaluate product functionality and quality.
Provides for technical support of Product Development Teams, Regulatory Affairs, and other CV laboratories.
Motivates employees to ensure engagement and a positive work environment
Ensures all personnel are trained in accordance with the SOPs, TMs, other documentation, and appropriate lab and safety procedures.
Manages appropriate levels of interface with Regulatory Affairs, Clinical, Sales, Manufacturing, and outside customers and suppliers and participates in / contributes to communications with these groups.
Other duties/responsibilities as defined by R&D management.

Requirements

EDUCATIONAL/EXPERIENCE REQUIREMENTS:
·        BA/BS degree in physical science with a minimum of 10 years experience or a MS degree in a relevant discipline with a minimum of 8 years lab management experience
·        Proficiency with managing a laboratories for a medical device company
·        Strong people management skills
·        Knowledgeable about GLP, cGMP, ICH and FDA requirements
·        Strong leadership and communication skills
·        Strong organizational skills
·        Ability to establish good working relationships with peers across and outside the organization
PREFERRED EXPERIENCE
·       Proven ability to coach technical professionals to achieve maximum performance
·       Effective at influencing and building strong working relationships across all levels
·       Strong leadership and communication skills are required.
·       Extensive analytical experience with a wide variety of analytical techniques
·       Extensive experience with GLP and / or GMP
·       Extensive experience with test method development, design verification, validation, risk management
·       Strong work ethic in accomplishing objectives. Able to deliver on multiple projects simultaneously
·       Effectively manage a large workflow and multiple projects at one time
·       Great ability for reasoning and logical deduction and to transfer between abstract and concrete concepts
·       Strong in problem solving. Able to solve complex problems that require creativity.

·       Proven ability to coach technical professionals to achieve maximum performance
·       Effective at influencing and building strong working relationships across all levels
·       Strong leadership and communication skills are required.
·       Extensive analytical experience with a wide variety of analytical techniques
·       Extensive experience with GLP and / or GMP
·       Extensive experience with test method development, design verification, validation, risk management
·       Strong work ethic in accomplishing objectives. Able to deliver on multiple projects simultaneously
·       Effectively manage a large workflow and multiple projects at one time
·       Great ability for reasoning and logical deduction and to transfer between abstract and concrete concepts
·       Strong in problem solving. Able to solve complex problems that require creativity.