Pharmaceutical Development Technician Jobs

Help deliver the required PDM inputs to the Gilead Enterprise Risk Management review and execute on that process.

Experience in the biotech or pharmaceutical industry with demonstrated cross-functional collaboration and leadership; deep knowledge about the biotech / bio-pharma segment.

Develop and manage PDM CAPEX plans, including evaluating critical spending tradeoffs and major project approvals. .

Bachelor’s degree and 12+ years of relevant experience, or master’s degree / PhD / MD with 10+ years of relevant experience.

Experience working across different cultures.

Strong leadership, self-direction, comfort and experience tackling ambiguous, complex problems.

Ph.D. and 15+ years of relevant experience

Experience contributing to IND & NDA Regulatory Filings

Experience managing tech transfers to internal & external stakeholders

Serve as technical lead for in-house early development and late-stage tech transfer of immediate and controlled release dosage forms.

Lead late-stage NCE Development activities

Work with Regulatory Affairs to develop filing strategies for US and EU

Applicable mechanical and project management experience

Experience | Skills | Knowledge

Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements and Good Documentation Practices (GDP)

Supports project team as operations expert through start-up, commissioning, qualification through licensure and ramp up of facility

Maintains detailed knowledge of equipment and processes

One year of GMP manufacturing/processing experience

Offer continuous improvement suggestions for efficiencies

Performs other duties as assigned by the Team Lead or Manager

Position requires performing other responsibilities as assigned

Prefer 2 years pharmaceutical manufacturing experience or experience in a manufacturing/production environment

A Forklift certification is preferred

MUST BE ABLE TO WORK ANY SHIFT

Effective and excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

Document activities using the computerized maintenance management system

Partners with maintenance personnel to reduce overall line downtime, and develop a deeper operational knowledge of equipment

One or more years of relevant work experience

Principled verbal and written communication and skills

Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines

Follows all written procedures, SOPs, cGMP regulations and safety requirements during manufacturing.

Carries out operations with strict adherence to cGMP and OSHA requirements.

for further information should be directed to the hiring manager.

Manager: Kevin Soltis Rate: $38.47

Adheres to the established manufacturing schedule for all assigned batches from start to completion.

Assists in the manufacture of pharmaceutical oral dosage products for use in clinical studies.

Should have good working knowledge of all areas of development – including CMC, non-clinical, clinical, project management and regulatory functions

5+ years’ experience in project management, leading multi-disciplinary project teams through the various phases of product development is preferred

Will effectively communicate project status to management and provide resolution of project issues.

Proficiency of regulatory development requirements in the US along with working knowledge for the RoW development

Proficiency of regulatory development requirements in the US with a working knowledge for RoW development

Expertise in the application of project management software (e.g. MS Project) and in the use of the project/portfolio management systems required

5+ experience in account management in the healthcare industry

Experience in account management or consulting within the oncology pharmaceutical industry

experience in account management or consulting within the oncology pharmaceutical industry

Self-motivated with strong discipline in time management and organization.

Strong communication skills and ability to build relationships with clients and prospects.

In-depth knowledge of the pharmaceutical industry, including patient support and advocacy programs.

Strong English language skills including writing ability and oral communication.

Set up and operate formulation and testing instrument, and manufacturing and packaging process equipment. Conduct instrument and process troubleshooting.

Write protocols, methods, standard operation procedures, and contribute to submission documents independently. Design experimental studies and write reports with minimal supervision.

Design studies and conduct evaluation and selection of raw material (APIs, excipients, primary and secondary packaging material, device component material etc.).

Design process development studies and conduct evaluation and optimization of manufacturing and packaging process for orally inhaled products.

Specialized or Technical Knowledge, Licenses, and Certifications Required:

To be considered for this position, you must meet the following qualifications and requirements:

Education Required: High School Degree or Equivalent Required

Solid Communication Skills and Good Documentation Practices

Experience with HVAC, Air Compressor System, DI Water System, Dust Collection System, Documentation Control System

Analyzing and Troubleshooting Equipment and Ancillary Utilities

Must satisfactorily complete all requirements for Pharmaceutical Packaging Technician I

Develop skills necessary to work with and clean all semi-automated and automated pieces of equipment

Understands GMP gowning and de-gowning requirements for each production area (primary, secondary and potent packaging suites) and ensures compliance

Clinical trial packaging or related manufacturing/operations experience preferred

Ability to work in a team environment, high attention to detail and above average organizational skills.

Medical, dental, and vision benefits effective day one of employment

Assist with setups and changeovers with adherence to SOPs and safety requirements

At least 1 year of manufacturing or related experience is preferred

Catalent offers rewarding opportunities to further your career!

Understanding specific cleaning agents used to clean equipment and manufacturing suites

Cleaning of equipment per specific details in Work Instructions

Ensure all cleaning activities are documented in equipment and room logbooks, accurately and compliant with SOPs and FDA cGMP guidelines

Lead AbbVie global drug product initiatives and manage direct reports.

Prior experience demonstrating independent critical thinking for technical problem-solving and driving fundamental science through innovative science is highly desirable.

Excellent communication and written skills are required.

Generate high-quality data based on sound scientific principles and prepare formulation data summaries, technical reports, scientific presentations, and regulatory documents.

Raise the external influence of Abbvie in the scientific community through external presentations, patent applications, and publications.

South San Francisco-based position with 10-20% business travel.

Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Entry level, 0-1 years of work experience required; 1-2 years of relevant experience preferred.

CGMP or prior work experience in a regulated environment preferred.

Prior pharmaceutical or CDMO experience preferred.

Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.

Excellent verbal and written communication and documentation skills required.

Must be able to assist in trouble shooting activities and repairs to production equipment under the guidance of more experienced technicians.

Demonstrated mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and conversions.

Demonstrated written and verbal communication skills are required.

Experiences in related GMP environment within biotechnology/pharmaceutical industry strongly preferred

Must obtain & maintain qualifications, as required, to perform the assigned work.

Must maintain all training requirements and regularly checks the LOS training system in order to complete all required training on time.

Manage own time and professional development, be accountable for own results and begin to prioritize own workflow.

Previous experience in cGMPs (current Good Manufacturing Practices) environment

Complete adherence to all plant safety and (current) Good Manufacturing Practices {also cGMP} regulations to the highest.

Assist with diagnosis and troubleshooting activities and execute in-process quality inspections.

Ensure adequate inventory of parts and materials prior to initiating a production run.

Identify and seek to implement process and safety improvement and perform all tasks in a safe manner.

Offer continuous improvement suggestions for efficiencies

Performs other duties as assigned by the Team Lead or Manager

Position requires performing other responsibilities as assigned

Prefer 2 years pharmaceutical manufacturing experience or experience in a manufacturing/production environment

A Forklift certification is preferred

MUST BE ABLE TO WORK ANY SHIFT