Analytical Technical Leader

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We are currently looking for an Analytical Technical Leader for our Souderton, PA location. The Analytical Technical Leader utilizes extensive experience in: HPLC, UPLC, GC, FTIR and dissolution. He/she will provide expertise and guidance to the analytical laboratory for quality control and method transfer activities.
 
Responsibilities include but are not limited to:
  • The Analytical Technical Leader will provide leadership to the analytical laboratory to aid the execution of release and stability testing, and participate and perform method development, method validation and method transfers independently in conjunction with the development group. The Leader will independently scope out projects and interface with clients as necessary to develop protocols and reports.
  • Assists Team Leader in the administration of all aspects of lab work including but not limited to stability work, developmental activities, reference standards and any investigations undertaken.
  • The Analytical Technical leader will be a self-motivated and self-directed individual who can accomplish the stated objectives even in the face of ambiguity. The leader has to work very well with both internal and external partners.
  • The Analytical Technical leader will be a member of the Analytical Leadership Team and will be expected to lead and coach other junior staff members.
  • The Analytical Technical leader will be expected to bring in new technologies into the group.
 
Qualifications
Education: 
  • Bachelors of Science Degree in Chemistry or related field required
  • Master or PhD in Sciences preferred
Required:
  • A minimum of five (5) years of cGMP experience in a regulated environment
  • A minimum of five (5) years of experience analyzing/supervising the testing of Drug Substance or Drug Product
  • A minimum of three (3) years of experience with a leadership role in the administration/coordination of a stability program
  • A minimum of two (2) years of method development, validation and/or method transfer
  • A minimum of three (3) yrs of experience in Documentation creation (CoA/SOP/Methods/protocols etc), Change Control, Deviations and OOS/OOT investigations
  • Demonstrated competency in a leadership role in the analytical laboratory with an emphasis on troubleshooting and resolution
  • A minimum of three (3)  years of experience in managing staff
  • Proficiency in HPLC, UPLC, FTIR, Dissolution, KFT and bench techniques
  • Current requirements for development, characterization, validation, transfer and comparability of methods
  • USP/EP/JP Compendia monographs
 
Preferred:
  • Cross-functional management
  • Management of contract laboratories
What can Almac Group offer you?
  • Medical, Vision & Dental benefits from the 1st of the month following start date
  • 20 days PTO per year, accrued monthly following start date
  • 12 holidays per year
  • Company paid Long and Short-term disability along with Life Insurance
  • 401k company contribution
  • Professional development programs/ continuous learning opportunities
 
 
Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry.  We are a privately owned organization that has organically grown over 50 years now employing 6,000 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life.
Embracing diversity is at the heart of enhancing Almac Group’s unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all.  Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.
 
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
 
Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.
 
 
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process.  Please email us at [email protected] to request assistance.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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