Associate Director, CMC

CATO SMS and Pharm-Olam, LLC have merged to form Allucent!

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

Summary:

The CMC Associate Director is responsible for assisting clients with Chemistry Manufacturing and Control (CMC) and related pharmaceutical development activities of drug, biologic, or medical device products. Responsibilities may include analysis/review of drug substance synthesis, pre-formulation and formulation evaluation, analysis of manufacture, scale-up and process validation, providing support of analytical methods development and validation, and evaluation of packaging and labeling components. The CMC Associate Director participates in Health Authority (HA) communications including correspondences, teleconferences and meetings. The CMC Associate Director prepares CMC-related regulatory content for HA submissions, reviews and authors reports, protocols and other scientific documents. 

The CMC Associate Director will serve on project teams in various capacities, including but not limited to: Subject Matter Expert, Technical Lead, Assistant Consulting Project Lead, and Consulting Project Lead. The CMC Associate Director may manage 1 or more direct reports.

Location: Europe or USA (Hybrid/Remote)

Responsibilities:

• Reviews and/or writes regulatory/scientific documents or sections thereof, with efficiency, accuracy, and independent thought.
• Contributes significantly to strategic/CMC discussions and associated documents/reports regarding drug, biologic, or device development.
• Guides the writing of regulatory/scientific documents written by other project team members.
• Has scientific knowledge of HA Regulatory Guidance and Regulations
• Interacts with various HAs, including preparation of meeting and briefing documents, participation in HA meetings and preparing responses to inquiries.
• Contributes significantly to strategic/CMC discussions and associated documents/reports regarding drug, biologic, or device development issues with primary emphasis on scientific aspects.
• Is competent with electronic common technical document (eCTD) format and requirements of regulatory submissions.
• Manages projects as assigned.
• Prepares product development plans and/or strategies from early development through Phase 4.
• Participates in meetings with clients.
• Performs other scientist related duties, as assigned.
• Performs work as instructed or independently.
• Actively supports staff learning & development within the company. 
• Provides guidance and advises Project Leads, and/or Project Teams 
• Adherence to project budgets and contracts including scope and scope changes, timeline deliverables and active management of resources.
• Manages projects as a Consulting Technical Lead as assigned.  
• Leads and/or participates in meetings with clients. 
• Provides mentorship to team members.
• Acts professionally with peers and clients, knows business etiquette.
• Applies company policies and procedures to resolve a variety of issues.
• Identifies and mitigates risk.
• Assures good communication and relationships with clients.
• Assists in the evaluation of potential technologies. 
• Assists with the review of business development proposals, project cost structures and participates in bid defenses.
• Monitors and evaluates industry trends to leverage service offerings to ensure business growth (new opportunities and expansion of current client business)
• Actively manages, develops, and strengthens client relationships, drives repeat business.
• Contributes and participates in client evaluations.

Requirements

• Requires a B.S., R.Ph., M.S., Ph.D., or equivalent de