Director, Analytical Development and Quality Control [JC-1402]

LakePharma

Hopkinton, MA, US
  • Job Type: Full-Time
  • Function: Life Sciences QA/QC
  • Post Date: 01/01/2021
  • Website: lakepharma.com
  • Company Address: 530 Harbor Blvd., Belmont, CA, 94002

About LakePharma

LakePharma is the leading US-based biologics contract research, development, and manufacturing organization (CRDMO).

Job Description

LakePharma is the leading US-based biologics contract research, development, and manufacturing organization (CRDMO). The company has developed a range of technologies and capabilities in antibody discovery, protein engineering, cell line development, protein optimization, and GMP manufacturing. With comprehensive technologies, integrated platforms, and five facilities located in key biopharma hubs on both the East and West Coast, LakePharma enables and supports the discovery and development of the biologics of tomorrow. 

 

Position Summary

The position of Director, Analytical Development and Quality Control will be responsible for planning and coordination of the Analytical R&D and Quality Control functions and will oversee all analytical development, testing and reporting for client driven internal CDMO workflows associated with GMP production suite activities as well as direct to client Analytical Services and QC Release Testing/Stability Studies. This position will provide the technical expertise required to manage analytical service development, release testing and environmental monitoring for 3 cGxP production suites.  This position will also include responsibilities for maintaining close alliance with Manufacturing, Process Development, Quality Assurance, R&D Assay Teams and Facility Support Operations team.  This position will report to the Sr. Director of Pharma Assays and Analytics Group

 

Essential Duties and Responsibilities

Establish robust analytical development strategies, plans, timelines and budgets and track status, progression, critical success factors and risk factors in the ongoing and planned CMC development projects including:

  • Method development and validation for control of raw materials, drug substance, drug product intermediates, and finished drug products
  • Development testing, analysis and technical support
  • Specification development for raw materials, drug substance, drug product intermediates, and finished drug products
  • Raw material evaluation, testing, release and vendor qualification
  • Clinical trial material evaluation and release testing
  • Stability study design, execution, monitoring, reporting, and data trending and analysis
  • Method transfer to contract manufacturing organizations

Responsible for Quality Control function for Phase 1/Phase 2 in-house production and Environmental Monitoring

  • Supports in technical audits of external manufacturing partners to ensure compliance with regulatory requirements and regulations
  • Partners with Quality Assurance to ensure that SOP's are in place and followed.
  • Provide training and guidance to partners (internal and external) on analytical research and development best practices

Responsible for development and implementation of analytical function

  • Provides strategic input into department structure, policies and procedures
  • Provides direction and leadership to internal and vendor staff
  • Develops staff through mentoring, training, coaching and feedback
  • Plans and directs work activities, establishes realistic goals and objectives, and monitors progress toward those goals so timelines can be met and be achieved
  • Ensures decisions are scientifically-sound and supported by data.

Provides recommendations and input on departmental policies, new service opportunities, service developmental strategies, procedures, resourcing, budgets, goals and objectives.

 

Present oversight quality control results at relevant meetings, including but not limited to, quality councils, business review meetings, partner compliance meetings, leadership team meetings etc. 

 

Coordinate responses to new and ad hoc requests in support of identified quality or compliance risks during audits and regulatory inspections.

 

Provide consultative support to the business with the purpose of continuous improvement

Requirements
  • Bachelor’s Degree minimum.  A Ph.D. or Master’s degree in the life sciences preferred.  Focus on pharmaceutical sciences with an emphasis on bioassay workflows and biologics highly desirerable.
  • 10+ years (or equivalent) in an analytical development and control function with increasing levels of responsibility 
  • Expertise in complex investigations, method development, validation and transfer and/or regulatory registration of drug products
  • Excellent communication and project management skills are required as this position is responsible for the scientific evaluation and coordination of work performed by internal partners
  • Strong leadership, interpersonal, oral and written communication and team building skills

Work Environment

Work is performed in an office and laboratory environment. May be exposed to biological and chemical hazards. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. Light to moderate lifting and carrying objects with a maximum lift of 30lbs. Must be able to work while wearing personal protective equipment such as safety glasses, gloves, and lab coats deemed necessary to protect testing and to protect employees. Work is to be performed on site.

 

Disclaimer

This job description is not necessarily a comprehensive list of all duties and responsibilities. The employer reserves the right to revise key functions of this position at any time. 

LakePharma is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.