Associate Director/Director of Quality Control/Analytical Development - Lexington, MA | Biospace
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Associate Director/Director of Quality Control/Analytical Development

WAVE Life Sciences

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Location:
Lexington, MA
Posted Date:
7/11/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Wave Life Sciences is seeking an Associate Director/Director of Quality Control/Analytical Development  to be responsible for the startup and management of a GMP Quality Control/Analytical Development department which will include the development, validation, qualification, and implementation of analytical test methods in support of process development, GMP production, and stability testing with emphasis on UPLC and LC-MS methods. The successful candidate must have extensive experience in the development and validation of stability-indicating and quantitative assays as well as strategic and tactical management of a laboratory in cGMP environment.  Exceptional technical and cGMP skills are a must for this position. Ability to adapt to a fast pace dynamic environment where priorities can change rapidly.

Ideal candidate will have oligonucleotide Quality Control experience. This position will be located in Lexington.

RESPONSIBILITIES/COMPETENCIES

·       Creates and innovates at the strategic level, while managing diligent execution at the tactical level.

·       Establish and direct QCAD/QC activities for GMP manufacture that will include method development and transfer, in process testing, raw material testing, method validation, Drug Substance (DS) and Drug Product (DP) release testing, DS and DP stability studies, reference standard characterization, etc.

·       Collaborate with Process Development and Manufacturing Operations to devise practical QC/AD solutions.

·       Provides scientific leadership in the generation of validation reports, regulatory documents, investigations and risk assessments.

·       Develop departmental key performance indicators (KPI) and analyze for opportunities to optimize department performance.

·       Responsible for representing the company during audits, visits, and technical calls.

·       Responsible for representing QC/AD across multiple functional groups including CMC team

·       Write, review and approve cGMP documentation (SOPs, protocols, technical reports, specifications, etc.).

·       Troubleshoot and resolve of technical and compliance issues

·       Analyze and interpret data.

·       Mentors and trains staff and acts as an analytical chemistry resource/SME

·       Create and meet objectives for timelines, budgets, and goals.

·       Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance development planning.

·       Maintains employee work schedules.

·       Identifies, recruits and retains top-notch talent.

·       Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication.

Requirements

PhD in Analytical Chemistry or equivalent with a minimum of 12 years of experience in an Analytical Development/Quality Control cGMP environment.

or

·       MS in Analytical Chemistry or equivalent with a minimum of 15 years of experience in an Analytical Development/Quality Control cGMP environment

·       Minimum of 6 years of leadership/supervisory experience.

·       Strong knowledge of cGMP regulations, building codes, safety and environmental requirements.

·       Proven track record and established leadership in analytics applied to clinical drug development and GMP manufacture.

·       Experience with clinical phase and commercial cGMP operations

·       Demonstrated ability to build a team and develop team members.

·       Demonstrated ability to manage, motivate and mentor scientific personnel and encourage teamwork.

·       Detail oriented and strong written and verbal communication skills.