Senior Contract Development Manager

About PSC Biotech

Who we are

PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloudbased software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.

Take your Career to a new Level

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which includes the opportunity to work with the most talented cohort of likeminded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.

Job Title: Senior Contract & Development Manager

Job Summary:

This position will report to the Contract & Development Manager Manufacturing. The ideal candidate will have previous experience in aseptic processing in a sterile manufacturing facility with cGMP and Quality System knowledge.

The candidate will have excellent troubleshooting skills using standard industry techniques

Position will be responsible for managing and executing nonconformance CAPA SICAR Change Control and metrics oversight responsibilities for the External Supply organization

Determines situations which require escalation to management

Communicate with all levels of the organization facilitate development of solutions to critical business issues and effectively define objectives to enable effective metric generation and reporting.

Facilitate daily scheduling meetings. Ensure current schedule is maintained accurate and up to date.

Be responsible for compiling maintaining and reviewing all necessary reports

Assist plan and implement continuous improvement ideas / opportunities

Contribute and assist with Corporate FDA IMB Auditors and other regulatory bodies during company audits.

Complete any other duties as requested by Site Manufacturing Management.

Requirements

Basic Requirements:

Be a resultsoriented person with excellent organizational communicational and team development skills with an ability to successfully interact with people create a team environment and generate cooperation

Demonstrated ability to deliver to team site and personal objectives

Able to successfully manage workload to timelines

Familiarity with basic project management tools

Demonstrated understanding and use of RFT techniques and lean manufacturing concepts

Strong ability to lead challenge and positively influence in an interactive team environment

Strong computer skills knowledge Quality tracking system (QMTS).

Basic Qualifications:

Master s degree or bachelor s degree & 2 years of directly related experience OR Associate s degree & 6 years of directly related experience OR High school diploma / GED & 8 years of directly related experience

Preferred Qualifications:

2 years of quality and manufacturing experience in biotech or pharmaceutical industry

Bachelor s Degree in a Science Field

Understanding of the applicable manufacturing/testing processes (i.e. API Drug Substance Drug Product Packaging Device manufacturing processes