Associate Director Technical Services - Pharmaceuticals
Epic Pharma LLC Epic Pharma LLC Laurelton, NY Laurelton, NY Full-time Full-time $100,000 - $160,000 a year $100,000 - $160,000 a year 14 days ago 14 days ago 14 days ago EPIC is a local Generic Pharma Company and if you are an energetic fast learner we are looking for you! We're right here in Laurelton, Queens - an easy commute, a business casual, family/team environment, competitive salary, benefits, paid time off, employee activities, performance management program, and more! If you see yourself as a proud contributor to the EPIC MISSION- providing patients with with a wide range of quality-infused and affordable medications developed and manufactured to the highest regulatory standards, and you fit the qualifications below, don't hesitate - send in your resume now! We're excited to meet you! This is a NEW POSITION at Epic Pharma.
The right candidate will lead various technical service activities including Tech Transfer & Validation Provide technical leadership for drug product tech transfer activities to enable successful commercial product launches of various dosage forms Participate in development teams for late phase assets, commercial site selection, design & evaluate tech transfer studies, generate & execute process performance qualification (PPQ) studies, write/review important sections of regulatory dossiers.
Work with drug product team & manufacturing site tech leads to develop & communicate a tech transfer plan Lead or advise on equipment & process validation activities Ensure high level of current technical knowledge is maintained within the development team Provide on-site support for tech transfer activities when needed Collaborate with Sourcing Dept.
for selection of raw materials & components when needed.
Lead or support significant technical investigations at other manufacturing sites Design complex technical projects or investigations, interpret diverse data & results, and recommend next steps Lead multiple projects within or across departments, and lead complex multi-site investigations if applicable Provide leadership support & technical consultation to other functions within the company Prepare & review tech transfer documents, validation protocols & reports Education & Experience Must have minimum Masters Degrees in Pharmacy or Engineering plus 10 or more years directly related experience in a Technical Services function within the Pharma industry.
Advance knowledge of formulation development, tech transfer, commercial manufacturing Hands on experience with various dosage forms, including oral, ophthalmic & injectables Detailed knowledge of drug product process & cleaning validation Experienced with use of statistical software to design DOEs & analyze process related data Strong cGMP & FDA regulatory knowledge Must be able to work effectively with internal partners & external vendors to deliver on project milestones.
Management Experience preferred and MUST be able to travel up to 25% of the time Epic Pharma is an Equal Opportunity Employer.
Job Type:
Full-time Pay:
$100,000.
00 - $160,000.
00 per year
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Parental leave Referral program Vision insurance Experience level:
10 years Schedule:
Monday to Friday
Experience:
Technical project management:
10 years (Required) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
The right candidate will lead various technical service activities including Tech Transfer & Validation Provide technical leadership for drug product tech transfer activities to enable successful commercial product launches of various dosage forms Participate in development teams for late phase assets, commercial site selection, design & evaluate tech transfer studies, generate & execute process performance qualification (PPQ) studies, write/review important sections of regulatory dossiers.
Work with drug product team & manufacturing site tech leads to develop & communicate a tech transfer plan Lead or advise on equipment & process validation activities Ensure high level of current technical knowledge is maintained within the development team Provide on-site support for tech transfer activities when needed Collaborate with Sourcing Dept.
for selection of raw materials & components when needed.
Lead or support significant technical investigations at other manufacturing sites Design complex technical projects or investigations, interpret diverse data & results, and recommend next steps Lead multiple projects within or across departments, and lead complex multi-site investigations if applicable Provide leadership support & technical consultation to other functions within the company Prepare & review tech transfer documents, validation protocols & reports Education & Experience Must have minimum Masters Degrees in Pharmacy or Engineering plus 10 or more years directly related experience in a Technical Services function within the Pharma industry.
Advance knowledge of formulation development, tech transfer, commercial manufacturing Hands on experience with various dosage forms, including oral, ophthalmic & injectables Detailed knowledge of drug product process & cleaning validation Experienced with use of statistical software to design DOEs & analyze process related data Strong cGMP & FDA regulatory knowledge Must be able to work effectively with internal partners & external vendors to deliver on project milestones.
Management Experience preferred and MUST be able to travel up to 25% of the time Epic Pharma is an Equal Opportunity Employer.
Job Type:
Full-time Pay:
$100,000.
00 - $160,000.
00 per year
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Parental leave Referral program Vision insurance Experience level:
10 years Schedule:
Monday to Friday
Experience:
Technical project management:
10 years (Required) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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