|Essential Duties & Responsibilities:
Key responsibilities of the position include, but are not limited to:
I. Support and execute day-to-day operations in non-GMP (trials and experiments) and GMP pilot plants (GMP batches manufacturing & packaging) at Kashiv/Amneal; Review & Approve formulation and process proposed by formulation team for pilot bio-study, scale-up, site-transfer, submission batch manufacturing and filing; Review critical lab data
II. Part of document control team:
i.Small scale to large-scale trial batch records review
ii.Create and/or review R&D Guidelines & Policies
iii.Create and /or review Standard Operating Procedures
iv.Create and/or review GMP batch records
v.Create and/or review GMP packaging records
vi.Create and/or review Process Evaluation/ Validation Protocols & Reports
vii.Cleaning Verification/ validation documents
viii.Review Stability Protocols
ix.Installation, Operation, Performance Qualifications of Equipment and Instruments
x.Inventory Control System Support (ANDA /NDA filings to Site Transfer to Process Validation and Launch)
xi.Create and/or review the ANDA/ NDA Filing Modules of related CMC sections with focus on Quality by Design Batch Plan/Execution, Process Engineering, Scale-up Process /Parameters Range and Controls and Related Reports
a.Fully trained in OSHA, DEA, EPA, FDA and related State / Federal Registers for GLP and GMP Guidances & work with Quality Team.
b.Trained in all SOPs at Kashiv except core Analytical R&D/ QC
c.Should train other employees to meet basic requirements of Technical Services roles and responsibilities
d.Basic knowledge and skills of operating key processing equipments: high shear mixers, blenders, fluid-bed (rotor, wurster, top spray for granulation and pellet coatings), pan-coating, milling, tabletting, encapsulation, hot-melt extrusion, etc.
IV. Business Support
a.Work on In-house assigned projects for ANDA/ NDA (505b2) and supervise scientists assigned to such projects
b.Be part of project management and planning team to help execute product milestones on time in efficient manner
c.Take lead in Third-Party Projects in Contract Manufacturing of R&D Products
Position Requirements and Qualifications:
Education and Experience:
•Prefer Ph.D. in Pharmaceutical Sciences with 3 to 5 years generic/ brand experience, or Masters with 6 to 10 years of experience.
•A minimum of five (5) years of Supervisory experience with and demonstrated progression. At least three (3) years of experience at a managerial level.
•Working knowledge on safety, quality and cGMP as they apply to the pilot plant activities.
•Some hands-on processing of pharmaceutical products, hands-on operations/training of pharmaceutical manufacturing equipment/instruments and familiarization of pharmaceutical raw materials.
•Includes basic training in the fields of business administration, accountancy, computer literacy (Windows: Power Point, Word, Excel; Inventory Management System: JDE, Filemaker Pro, etc.) or similar vocations generally obtained through completion of a high school diploma program or university.
•Must demonstrate strong organizational, interpersonal and leadership capabilities with excellent oral and written communication skills.
•Ability to plan and prioritize multiple complex activities simultaneously
•Must thrive in a team-oriented and entrepreneurial environment
•Some travel required
|Kashiv Pharma, LLC|
State or Province