Please contact the recruiter directly if you are interested.
From: Debra Pohl <email@example.com>
Date: Thu, Jun 28, 2012 at 5:53 PM
Subject: Manufacturing, Science and Technology review
To: Edith Paul <firstname.lastname@example.org>
We have just started a search for a Head of Manufacturing Science & Technology within a major pharma company in the NJ/NY area (relocation provided). This is a newly created position and will start up and manage this group (to 25 employees). The facility is engaged in high volume solid dosage manufacturing and is expanding. They are seeking a seasoned individual with strong experience in packaging, engineering and validation within the solid dosage arena. *Prior experience with start-ups, expansions and bringing in new technologies desired.
*In addition, we continue our search for a Director Validation within this company requiring strong, broad validation experience within a solid dosage environment and a well developed forward management style and experience.
I have included below a description of the Head MS&T role (as well as a list of other searches we are working on nationwide) for your review. Please let me know if you or someone you know may be interested.
PLEASE network this email to others in the industry. Networking is a powerful tool often the means by which many find their next great career move. With the current economic state and the volatility of the industry at this time everyone needs to keep an eye out for themselves as well as others. I thank you for your consideration and support and look forward to hearing back.
Head of Manufacturing Science & Technology
Make the necessary internal and external benchmark in the scientific environment in order to encourage and expand knowledge. Promote Excellence in Packaging and Galenic Processes in the plant, as well as new products or technologies, embracing the concept of Quality by Design, DOE and PAT as applicable. This activity includes adherence to GMP requirements, guidelines, SOPs, as well as respecting the laws, policies and procedures on HSE, with attention to the protection of company assets and compliance with the Code of Conduct.
· Assure transfers and new product launches are executed to the highest Compliance standards while meeting agreed upon timelines.
· Responsible for all Process validation activities including preliminary QRA, APR
· Provide technical support in impact assessments relating to API variant, excipients, equipment change, temperature excursions, etc and assure that the evaluation, selection, and implementation of manufacturing equipment are robust, reliable, and aligned with Company manufacturing strategy.
· Conduct technical validation studies resulting from major changes
· Ensure alignment through different areas of expertise within MS&T, promoting synergies to increase knowledge of its members
· Assure evaluation, selection and implementation of manufacturing and packaging equipment are robust, reliable and aligned with Company manufacturing strategies
•Ensure process robustness using Lean tools
· Evaluate and recommend future state-of-the-art production systems for PharmOps site
· Conduct process capability studies of weak point products
· Support MS&T staff on execution of process improvements, scale-ups, and new package design and justification projects.
· Provide oversight that process justification batches generate sufficient process knowledge by thoroughly testing critical variables.
· Coordinate and study weaknesses in the manufacture of products already on the market
· Provide technical guidance on prioritizing new projects, operational process improvements, equipment re-qualification/routine re-validation, Annual Product Reviews, Analytical Method and product Transfers
· Assure that technical capability training and guidance are provided on a routine basis to MS&T, PU and Quality members to increase their technical knowledge
· Develop and provide coaching to the staff of MS&T, identifying their development needs / learning and performance standards including succession planning for the team.
· Assure trainings where required to MS&T members for assigned new projects or tasks are provided
· Education: BS in Science, Pharmacy or Chemical Engineering MS or PhD preferred, or equivalent experience
· Relevant Experiences
· Extended technical knowledge in area of own expertise
· Minimum 5-10 years experience in pharmaceutical formulation, process development, or manufacturing technology (with PhD)
· Minimum 10+ years experiences in pharmaceutical formulation, process development or manufacturing technology (without PhD)
· Strong Statistical background, minimum IQP Silver certification (or Green Belt equivalent) statistics level. Experience
· in DoE and Gage R&R
· Fundamental understanding of standard pharmaceutical analytical testing
(For detailed job descriptions, please visit our website at www.arcstaff.com)
JOB TITLE STATE
Senior Director, Analytical R&D and QC CA
Associate Director, Biostatistics (2 positions) CT
Programmer/Analyst I NY
Associate Director, Clinical Operations CT
Clinical Operations Manager NJ
Study Manager NJ
Associate Director – Safety Systems NY
Senior Drug Safety Associate NY
Drug Safety Associate CT
Senior Process Engineer NY
Head of Manufacturing, Science and Technology NY
MARKETING, SALES AND TRAINING
Division Sales Manager NJ
QUALITY CONTROL (QC)
Manager, Quality Control NJ
QUALITY OPERATIONS (QA)
Manager, Quality Systems IL
Auditor - Senior Auditor, Quality Systems NJ
Quality Specialist III - GCP Audit CT
PRODUCT & PROCESS DEVELOPMENT
Senior Process Engineer NY
Head of Regulatory Affairs MN
Director Regulatory Affairs Global Project Lead, Early Development NJ
Associate Director, Global Regulatory Affairs MI
Senior Director Regulatory Affairs NJ
Senior Regulatory Affairs Manager NJ
Division Sales Manager NJ
Director, Validation NY
Senior Process Validation Specialist/Engineer NY
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