Looking for Successful Leaders

This position requires understanding of the generic pharmaceutical product development process including pre-formulation, formulation design of experiment, QbD, scale-up, technical transfer and ANDA submission activities. Each formulator will have expertise in pharmaceutical processes including granulation, blending, fluid bed coating/ drying, milling, drying, compression or encapsulation and pan coating for tablets or capsules, while monitoring stability study results.

Primary Responsibilities

Formulation & Process Development

  • Design and execute experimental studies to support the development of solid oral dosage forms (Tablets & capsules), as defined by management/customer, and assume the responsibility to meet project specific timelines and objectives.
  • Independently develops formulations for tablets & capsules and other delivery forms.
  • Formulators should be able to demonstrate successful BE / PK outcomes. Maintain a working knowledge of cGMPs, DEA requirements and FDA guidance’s documents. Familiar with Design of Experiment and QbD tools.
  • Regular operation of R&D and GMP scale up equipment, such as v-blenders, fitz mill, comil, tablet compression machine, Malvern particle size analyzer, Air Jet Sieve analysis, Granulator etc.
  • Technical operation of Fluid bed technology for extended release, sustained release modified-release and orally disintegrating solid oral dosage forms.
  • Responsible for coordination and execution of bench top, pilot, manufacturing scale-up and verification batches. Provides technical and scientific input, support and assistance to other technical disciplines.
  • Prepares stability, consumer, and clinical samples.
  • Prepares, reviews, and/or approves stability protocols. Monitors, evaluates and summarizes the results of R&D drug development stability studies.

Product Tech Transfer

  • Participate as lead scientist in technical transfer of manufacturing processes in-house from clients and between Process Development and GMP Manufacturing groups.
  • Assists in the development of scalable processes with improved product yield and robust manufacturing systems.
  • Attend weekly teleconference with client and project manager to lead formulation tech transfer activates.
  • Participates in non-GMP engineering manufacturing runs in the GMP manufacturing suites.
  • Accurately documents data and completes batch records.
  • May cross train and/or focus in various tasks including R&D and cGMP manufacturing.
  • Maintains cGMP environment when working in manufacturing suites and remains current in GMP training. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Documentation

  • Maintain accurate records & R&D note-books of all development projects. Prepares technical documents relevant to area of responsibility such as SOP’s, electronic master batch records, raw material and product specifications, technical reports, lab book documentation and technology transfer documentations.
  • Preparation of manufacturing documentation, including batch records and specification sheets.
  • Preparation of pharmaceutical development reports and other technical documentation required for regulatory submissions.
  • Prepare and maintain weekly progress reports for every project and present technical data to team.

Intra & Extra Departmental Skills

  • Perform semi-complex adjustments to laboratory and production equipment/instruments, calibration and preventative maintenance of equipment and appropriate documentation. Perform weekly inspection of R&D labs.
  • Interfaces with other operating units (intra & extra departmental activities), such as cGMP Production department.
  • Ability to interface with Manufacturing, R&D, Quality Control, Quality Assurance, Regulatory Affairs, management personnel, customers, outside vendors and suppliers.
  • Ability to work with minimal supervision required.
  • Proficient in oral and written communication skills as well as effective organizational and supervisory skills and the ability to make presentations and recommendations in the area of responsibility.
  • Consults and interacts closely with other departments to define the formulation and manufacturing process.

Qualifications

MS/Ph.D. in Pharmaceutical Science, Chemical Engineering, or related science typically with a minimum 1-4 years of pharmaceutical or related work experience in the field (Preferred).

-OR-

BS in Pharmaceutical Science, Chemical Engineering, or related science typically with a minimum 5-10 years of pharmaceutical or related work experience in the field.

Familiar with Microsoft Office (i.e., Excel, PowerPoint, Word, Mini-Tab).

Physical Requirements

The employee is required to stand, walk, push, pull, twist, reach overhead, and bend to the floor; exert 10-20 lbs. of force frequently, and/or lift up to 50 lbs; occasionally uses step ladders; also climbs stairs. Visual accommodation is necessary for reading documents and making scientific observations. Must be able to hear alarms, detect machine sounds and malfunctioning equipment to identify and diagnose changes so appropriate action can be taken.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

If you’re interested in joining a diverse team where you can make a difference, please contact us at

Contact Tedor Pharma

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