Sr Director, Technical Operations

BEST FORMULATIONS LLC•Industry, CA

42d•$180,000 - $210,000•Onsite

About The Position

We are a trusted partner to our customers when it comes to innovation and have one of the strongest R&D, product formulation and technical teams in the industry. We are recognized as the leader in plant-based softgel innovation and our ability to encapsulate difficult formulas. We seek out innovation across our entire business and pass that knowledge and expertise to our customers. As a Director of Technical Operations, you will be responsible for all aspects of product scale-up and commercialization activities, and supports operations by identifying and implementing process improvements to improve product quality, reduce operating costs, and increase production capacity. As an integral part of continuous improvement efforts, provides leadership, guidance and training to improve efficiencies in operations. Explores relevant enabling technologies, with focus on driving cost savings. Provides functional technical support to Manufacturing, Quality and other functional areas.

Requirements

Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemical Engineering, Food Science, or related field.
Five (5) or more years in nutraceutical or pharmaceutical manufacturing, with at least 3 years in a leadership role.
Proven experience in CDMO operations.
Expertise in process optimization, scale-up, and technology transfer for soft gel manufacturing.
Knowledge of raw material qualification, gelatin alternatives (vegetarian/vegan), and stability testing.
Proficiency in equipment validation, IQ/OQ/PQ, and CAPA systems.
Any combination of experience, education, and training that will provide the level of knowledge, skills, and ability required for the job.

Responsibilities

Creates strategic plan for Technical Operations group that supports the strategic vision of the company.
Performs all supervisory duties for Technical Operations team.
Conducts financial analysis for new projects (ex: Capital expenditure and ROI analysis).
Works with R&D and Supply Chain on technical transfer, product reformulations and material substitutions.
Conducts process monitoring activities, and performs machinery capability studies.
Conducts & leads production trouble-shooting, identifies and implements viable solutions.
Identifies and delivers advancements in continuous product/process improvements.
Continuously explores, identifies and develop innovative proprietary solutions and cost savings.
Lead or assist in CAPA or DOE activities.
Review formulations, MBR, Batch records, protocols, change controls and other process instructions to confirm capability and capacity.
Generate Process Qualifications Protocols (PQs) and perform Process Qualifications.
Work closely with Engineering, Operations and R&D on equipment selection process.
Perform Installation Qualifications (IQ) and Operational Qualifications (OQ) activities.
Maintains accurate records of all projects and assignments.
Follow established department SOP's, cGMP regulations, and batch record instructions.
Complies with all Company policies and procedures, including safety rules and regulations.
Maintains a safe work environment and operates in a safe manner.
Perform other related job duties related to the job, as assigned by management.