JCL CONSULTING

Navigating BioPharma Hurdles

  • Project Management

  • Program Development

  • Compliance Oversight

  • Business Process Optimization 

  • Internal Alignment

  • Partner Company Alliance

  • Vendor, CMO, Relationship Management

 
Working Together

ABOUT

JCL Consulting exists to provide clients in the Pharmaceutical, Biotechnology, and Medical Device industries with highly reliable, highly accountable Project, Program, and Alliance Management.

Every task is approached with a focus on maintaining an openly communicative and collaborative relationship-based foundation.  All internal stakeholders and external partners are crucial to success, and maintaining an open flow among cross-functional teams and departmental silos is primary.

Compliance, Operational Excellence and Business Process efficiencies are always kept in sight, and recommendations are always available regardless of the core project goals.  

What can a Client Expect?  

Professionalism. Dependability. Expertise. Results.


Above all, unwavering ownership of the task at hand.  Clients never face the uncertainty of not knowing where the buck stops.

 

SERVICES

JCL provides premium project management and related services with the express intent of giving clients an expereince that surpasses their expectations.

PROJECT MANAGEMENT

  • Exec Leadership / Specialty

  • Manufacturing

  • Laboratory

  • Product Development

  • Program Development

  • Compliance Critical

  • Operational Excellence

  • General

COMPLIANCE MANAGEMENT

  • Quality Assurance and GxP

  • Gap Analysis and Remediation

  • Regulatory submission and interaction

  • Validation and Qualification

  • Business and Internal Compliance

ALIGNMENT / ALLIANCE

  • Cross-functional and interdepartmental alignment

  • Partnership and contract management

  • CMO and vendor oversight

  • Liaison and relationship management

  • Internal and External communication streams  

 

INDUSTRY HISTORY

GLAXOWELCOME

BAYER

MERCK

NOVO NORDISK

GENENTECH

CERUS

 

PRINCIPAL

Meet James

James Lee began his career in the Pharma industry in the world of Aseptic Validation, quickly moving into all forms of industry Validation including Computer Systems.  Along the way he was heavily involved in QA and Compliance management and activities and dove head first into Project Management with the start of his first company on the East Coast.

It was with his first company, and his primary client, Merck, that he began to move from purely SME contributions and Project Management into a more focused involvement on corporate alignment and improving communications across the hardened walls of departmental silos.   With a natural aptitude to liaise, translate technical to non-technical language and manage professional relationships, James has always kept strong communications as an integral and central of every endeavor. 

Though Pharma and Biotechnology are his home, much of James' leadership skill set was sharpened from executive exposure in other sectors as well.  Such experiences range from founding and growing companies while nurturing intricate partnerships, to working with VCs and Fortune 500 CEOs and Presidents.  From mentoring startups to overseeing a corporate consolidation.  This diverse experience has enabled him to bring a wider lens to the table for his clients. 

James now operates exclusively as the Principal for JCL Consulting, whose mission is to bring calm and steady leadership to Pharmaceutical, Biotechnology and Medical Device project, partnership and business needs.

 

LEADERSHIP

My Approach and Values

OWNERSHIP

Failure to take ownership in a meaningful way is a fast way to miss your companies goals.  Delegation is a must for any successful leader, however, that does not allow leadership to wash their hands of bad outcomes.  To successfully solve a problem or create a solution a leader must own it - for better or worse.

INITIATIVE

Step up to the plate, and don't hesitate to put your best efforts on the line no matter what the adversity may or may not be.  Be the one who grabs the situation with both hands and leads without fear in their eyes.

INNOVATION

When no solution is readily available, it's time to shine.  Innovation requires the willingness and ability to look at situations from unusual angles and find paths forward from unlikely sources.  It's an opportunity to bring your uniquely diverse skills and experience to the table and create!

LISTEN

Listen to everyone. Period.  The custodian will have a different perspective than the CFO, and both may have wonderful ideas.  Never forget the distinct difference between hearing someone and listening to what they are saying.

COMMUNICATE

Correct communication is beyond spreading the word, though that is crucial.  Understand who you are communicating with, their likely level of technical understanding, the cadence of correspondence needed for them to use the information effectively.   Clarity and brevity rule the day.

 

LET’S CONNECT

Reaching a Deal
 

©2018 by James Lee. Proudly created with Wix.com