Job description

Title: Associate Director/Director, Technical Operations and Manufacturing Scale up Program Management

Status: 6-month contract

Location: Hybrid Onsite in Lexington, MA 3 days a week

Compensation: $60-$80 depending on experience

Overview

Seeking an experienced contractor who can help drive and support technical operations and commercial manufacturing scale up. This individual will integrate efforts across R&D, technical operations, manufacturing, commercial to meet critical milestones to advance programs and the platform. They will be a key part of the team working closely with external technical partners and Commercial Manufacturing partner to scale production, and will be responsible for developing and managing complex, multidisciplinary project plans and timelines. They will have a deep understanding of early to late-stage clinical development, CMC, and manufacturing scale up and commercialization, and will have experience working with external partners and CDMOs and successfully managing multiparty business relationships.

This role is hybrid, with onsite work 3 days/week in our Lexington office.

Day to Day Responsibilities

Work closely with heads of Technical Operations and Engineering to define and drive key projects and initiatives internally and with 3rd parties
Proactively identify risks, gaps,and resource bottlenecks; drive scenarioplanning; develop and implement mitigation plans.
Lead all aspects of operational planningand execution such as timeline and milestone development and tracking, team meeting management/minutes, decision making support, and internal reporting and communication.
Lead discussions with external partners on program plans and execution; proactively identify potential issues/risks and develop mitigation plans
Support strong cross-functional communication by building solid working relationships across the organization and with external partners

Experience Required:

Bachelor’s degree in life sciences, engineering or related field. Advanced degree(MS,
PhD or MBA) preferred. PMP certification is a plus.
Minimum 10 years' experience in biotech/pharmaceutical industry in relevant functional disciplines with responsibilities from clinical through commercial stage programs
Direct experience with tech transfer and manufacturing scale up initiatives including collaborations with external partners and CDMOs
Excellent project management and business operations skills, including utilizing Smartsheets, MS projectand relevant tools to createproject plans, with track record of managing projects on time and budget
Strong alliance management skills and demonstrated sucess working with external partners to execute on significant business initiatives and relationships.
Proven relationship building skills, including the gravitas necessary to push and pull information
Excellent communication skills (interpersonal, verbal and written)including an abilityto communicate complex issues simply and crisply
Demonstrated ability to work in ambiguous/changing conditions and understand complex projects with multiple inputs outputs, and variables; great attention to detail
Ability to work independently in a fast-paced, innovative, results-driven environment while remaining flexible, proactive, resourceful, and efficient
Ability to create and foster effective relationships, motivate others influence without authority, and collaborate at multiple organizational levels.
Excellent analytical and problem-solving skills with the ability to adapt to changing priorities and deadlines