Careers

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Positions


Job Openings


Manufacturing Technician I/II

Dept: Manufacturing
FLSA Status: Non-exempt

Position Summary

The Manufacturing Technician is responsible for supporting and performing routine procedures associated with the manufacture of the customer’s product with minimal direction from Supervisor.

Manufacturing Technicians responsibilities include performing environmental monitoring, cleaning and sterilizing of glassware, cleaning of clean-room suites, manufacturing preparatory activities and clean-up, assist in formulation, visual inspections, labeling and packaging. They may be aseptically qualified to perform aseptic manufacturing set-up, filtration, filling and closure of product. With sufficient Bioserv training, they may be a primary operator of complex equipment and processes, and additional tasks that are assigned by Management in compliance with QSR’s, SOP’s, and written procedures with direction from the Project Coordinator and/or Supervisor. Manufacturing Technician is responsible of completing other activities assigned by Supervisor.

Essential Duties & Responsibilities

  • Perform environmental monitoring and complete documents associated with the activity.
  • Responsible for cleaning and sterilizing of glassware and other materials that can be sterilized.
  • Perform cleaning of cleanroom suites.
  • Responsible for staging materials and equipment prior to manufacturing activities.
  • Assist in formulation of product.
  • Perform aseptic filtration, filling and crimping of product.
  • Perform visual inspection, sampling, labeling and packaging of product.
  • Identify discrepancies during manufacturing activities and notify Project Coordinator, Supervisor, and QA to ensure actions are taken in a timely manner to prevent deviations and non-conformances due to incorrect documentation.
  • Assist with other cross functional teams on an as needed basis to ensure company’s goals and objectives are met.
  • Other duties as assigned by Management.

Position Requirements:

Education Required

High school diploma or equivalent is required. College coursework in the sciences is preferred, or equivalent work experience is required.

Experienced Required

Recommended 1-2 years of experience in the pharmaceutical or related industry. Experience with both paper and electronic systems preferred. Basic word processing skills are desirable.

Specialized or Technical Knowledge, Licenses, or Certificates Needed.

Knowledge of GMPs required. Aseptic manufacturing experience is strongly preferred. Must be a team player, willing to learn, and able to work flexible hours. Occasional heavy lifting up to 50lbs, standing, sitting, controlled hand movements, repetitive motions, some pushing and pulling.

Travel Requirements

0-10% (Between San Diego Sorrento divisions not included)

Competencies: 

Planning & Organizational

  • Prepares long –term and short term plans for the development of the department based on corporate goals. Develops action plan for streamlining activities of the department and increase efficiency.
  • Must be very meticulous, well-organized and pay attention to detail.

Interpersonal

  • Excellent communication skills when communicating with management, colleagues, peers and management of other departments, third parties and regulatory agencies. Must be friendly, possess good interpersonal skills and a team player.

Communication

  • Excellent verbal and written communication skills. Capable of communicating effectively in English with all departments, management, third party contractors and auditors.

Autonomy and Independence

  • Interact with all team members as needed and capable of working independently with little supervision.

 

Physical Requirements:
Activity Never
(0%)
Occasionally
(1% – 19%)
Frequently
(20% – 79%)
Constant
(80% and above)
Visual Acuity X
Hearing X
Oral Communication X
Written Communication X
Walking X
Prolonged Standing X
Lifting (under 25 lbs.) X
Lifting (over 25 lbs.) X

Validations Manager/Engineer

ABOUT US

Bioserv, a Sorrento Company, is a leading contract manufacturing service provider whose core competencies are centered in aseptic and non-aseptic drug, medical device or reagent manufacturing; bulk formulation filtration; fill/finish; lyophilization services; labeling and finished goods assembly; kitting and packaging; as well as controlled temperature storage and distribution services to support Pre-Clinical, Phase I and II Clinical Trial drug products.

WHAT YOU’LL DO:

The Validations Manager/Validations Engineer is responsible for identifying Validation requirements for equipment, processes and analytical methods for Bioserv Corporation and Bioserv customers. The Validations Manager/Validations Engineer is responsible for responding to validation issues, authorizing Validation documents, revising existing Validation documents, analyzing Validation data, recommending and implementing remedial/corrective actions and overseeing the maintenance of the Validation database.

Essential Duties & Responsibilities

  • Lead and assist team members with validations: write IQ/OQ/PQ, review equipment, utilities, HVAC, facilities validation protocols/reports (URS/DQ/IQ/OQ/PQ)
  • May act as process owner or QA reviewer for change controls of protocols, SOPs, specifications, validations, and Forms related to Validation activities; ensure Change Control activities are well documented; follow up on open Change Controls and assess impact of changes on validation and key systems
  • Coordinate validation schedules with departments and customers
  • Execute validation
  • Analyze results and generate test reports and recommendations
  • Troubleshoot validation methods and/or instrumentation
  • Provide technical expertise for the generation of protocols and review of reports of validations of temperature controlled units, HVAC systems, water supply, autoclaves, depyrogenation ovens, Quality System computer programs, analytical equipment and methods
  • Task and support QA personnel to meet Quality and Manufacturing needs
  • Perform and/or review quality investigations and customer processes for CAPAs, NCMRs, Complaints, and Deviations that are related to validations; review reports to ensure root cause analysis was performed using Quality Tools (e.g. Ishikawa Diagram, 5 Why’s, DMAIC, etc.)
  • Perform or assist with preparation for FDA and other regulatory agency audits, inspections and customer audits
  • Perform or assist in internal audits and external audits; write internal audit reports and follow up on completion of any open corrections or corrective actions deemed necessary that were communicated and documented to the auditee
  • Ensure adequacy of validation procedures for phase appropriate cGMP compliance; must be able to identify deficiencies and discrepancies during internal audits, walk-through, for cause or impromptu audits and documentation audits; ensure management is notified and actions are taken to correct/address the quality problem(s) in a timely manner
  • Provide oversight for the selection and performance of any validation contract services
  • Prioritize work in alignment with company priorities
  • Assist with all QA Functions in the department, as needed

EDUCATION AND QUALIFICATIONS:

Education Required

BS or MS degree in a science discipline e.g., Life Sciences, Chemistry, Biology, Microbiology.

Experienced Required

Minimum 5 years of experience in the pharmaceutical, biotech or related industry. Hands-on experience with a paper, electronic or hybrid systems preferred. Strong knowledge of validations s required. FDA and/or other regulatory agency experience required.

Specialized or Technical Knowledge, Licenses, or Certificates Needed

  • Strong GMP background is required. Experience with writing GXP documents to meet requirements of phase appropriate cGMPs.
  • Must have knowledge of 21CFR210-211, 21CFR600-610, ICHQ7, ICH QS, Q9 & Ql 0. Experience with authoring Quality Agreements, Business Supply Agreements, CMC Section, Analytical Reports, is a plus.
  • FDA inspections and/or other regulatory agency inspections experience is highly desired.
  • Strong written and verbal communication skills, specifically technical, scientific, communications and oral presentations.

YOUR REWARD:

  • Support scientists who are on the leading edge of immunotherapies for the treatment of cancer.
  • Earn a competitive salary that allows you to focus your attention on your passion.
  • A comprehensive benefits package including medical, dental, vision, life and disability insurance, matching 401k, 10 paid holidays, and flexible PTO, plus stock options.

If this sounds like the right career to fit your personality and interests, please apply, we’re looking forward to meeting you!

*To apply, please visit: https://sorrentotherapeutics.bamboohr.com/jobs/view.php?id=214.

Principals only. Recruiters, please don’t contact this job poster.

Sorrento Therapeutics, Inc. is an Equal Opportunity Employer

Warehouse Specialist

ABOUT US

Bioserv, a Sorrento Company, is a leading contract manufacturing service provider whose core competencies are centered in aseptic and non-aseptic drug, medical device or reagent manufacturing; bulk formulation filtration; fill/finish; lyophilization services; labeling and finished goods assembly; kitting and packaging; as well as controlled temperature storage and distribution services to support Pre-Clinical, Phase I and II Clinical Trial drug products.

WHAT YOU’LL DO:

  • Responsible for shipping and receiving domestic and international orders
  • Assess and monitor warehouse transactions
  • Assist in Conduct Cycle Count Inventory processes to ensure accuracy and timely execution
  • Maintain adequate storage for warehouse inventory
  • Act as liaison between the warehouse and customer service (internal and external)
  • Assist with Finance Department on closing out invoices
  • Other duties as assigned

EDUCATION AND QUALIFICATIONS:

  • High school diploma/GED required; college coursework in the sciences is desirable
  • IATA and Forklift certified required
  • 1-2 years of experience in the inventory management or related field, preferably in a regulated environment
  • Hands-on experience with a paper Document Control System
  • Experience with both paper and electronic or hybrid systems
  • Strong knowledge of GMPs
  • FDA and/or another regulatory agency experience
  • Knowledge of computerized UPS and FedEx shipping program
  • Strong computer skills, including Microsoft Word and Excel

YOUR REWARD:

  • Support scientists who are on the leading edge of immunotherapies for the treatment of cancer.
  • Earn a competitive salary that allows you to focus your attention on your passion.
  • A comprehensive benefits package including: medical, dental, vision, life and disability insurance, matching 401k, 10 paid holidays, and three-weeks’ PTO, plus stock options.

If this sounds like the right career to fit your personality and interests, please apply, we’re looking forward to meeting you!

*To apply, please visit: https://sorrentotherapeutics.bamboohr.com/jobs/view.php?id=226.

Principals only. Recruiters, please don’t contact this job poster.

Sorrento Therapeutics, Inc. is an Equal Opportunity Employer

Manufacturing Technician I

ABOUT US

Bioserv, a Sorrento Company, is a leading contract manufacturing service provider whose core competencies are centered in aseptic and non-aseptic drug, medical device or reagent manufacturing; bulk formulation filtration; fill/finish; lyophilization services; labeling and finished goods assembly; kitting and packaging; as well as controlled temperature storage and distribution services to support Pre-Clinical, Phase I and II Clinical Trial drug products.

WHAT YOU’LL DO:

Under direct supervision, the Manufacturing Technician I will be responsible for supporting and performing routine procedures associated with the manufacture of the customer’s product. This individual will work independently once they are trained and experienced with technician tasks.

Essential Duties & Responsibilities

  • Perform environmental monitoring and complete documents associated with the activity
  • Clean and sterilize glassware and other materials
  • Perform cleaning of cleanroom suites
  • Stage materials and equipment prior to manufacturing activities
  • Assist in formulation of product
  • Perform aseptic filtration, filling and crimping of product
  • Visual inspection, sampling, labeling and packaging of product
  • Identify discrepancies during manufacturing activities and notify management and QA to ensure actions are taken in a timely manner to prevent deviations and non-conformances due to incorrect documentation
  • Assist cross-functional teams to ensure Company’s goals and objectives are met
  • Other duties as assigned

EDUCATION AND QUALIFICATIONS:

  • High School diploma or equivalent; College coursework in sciences preferred
  • 1-2 years of experience in the pharmaceutical or related industry
  • Experience with both paper and electronic systems
  • Basic word processing skills
  • Knowledge of GMPs
  • Aseptic manufacturing experience
  • Team player

YOUR REWARD:

  • Support scientists who are on the leading edge of immunotherapies for the treatment of cancer.
  • Earn a competitive salary that allows you to focus your attention on your passion.
  • A comprehensive benefits package including: medical, dental, vision, life and disability insurance, matching 401k, 10 paid holidays, and three-weeks’ PTO, plus stock options.

If this sounds like the right career to fit your personality and interests, please apply, we’re looking forward to meeting you!

*To apply, please visit: https://sorrentotherapeutics.bamboohr.com/jobs/view.php?id=268.

Principals only. Recruiters, please don’t contact this job poster.

Sorrento Therapeutics, Inc. is an Equal Opportunity Employer

Project Coordinator

ABOUT US

Bioserv, a Sorrento Company, is a leading contract manufacturing service provider whose core competencies are centered in aseptic and non-aseptic drug, medical device or reagent manufacturing; bulk formulation filtration; fill/finish; lyophilization services; labeling and finished goods assembly; kitting and packaging; as well as controlled temperature storage and distribution services to support Pre-Clinical, Phase I and II Clinical Trial drug products.

WHAT YOU’LL DO:

The Project Coordinator is responsible for coordinating and running processes associated with the manufacture of the customer’s product in manufacturing. This includes working with Project Managers in communication with the customer, ensuring inventory is available to begin the process, and coordinating the scheduling of the job including the needs of personnel, equipment and space. The Project Coordinator is directly involved in the set-up, formulation and aseptic filling and lyophilization of buffers and solutions, and the timely completion of all associated documentation throughout the entire process. They are to ensure that personnel follow all regulations and written procedures applicable to the job. Project Coordinators will also write procedures, perform validations, and investigate failures as necessary. The ideal candidate should be able to work with minimal instructions and should be able to provide some direction to area technicians.

Essential Duties & Responsibilities

  • Manufacture of product as assigned by management in compliance with applicable regulations (e.g. cGMP, ISO’s, QSRs) with minimal direction from the Manufacturing Supervisor; follow written procedures and verbal instructions
  • Ordering materials, equipment and supplies for production
  • Prepare for jobs in advance by staging materials in the appropriate areas
  • Coordinate the scheduling of product, space, and equipment with management
  • Perform aseptic formulations of buffers and solutions
  • Perform aseptic filtration and filling operations
  • Ability to operate a variety of equipment without assistance or direction, including but not limited to: shrink wrapper, powder filler, liquid filler, torque wrench, pH meter, conductivity meter, dry heat oven, mixer, lyophilizer, autoclave and other equipment related to manufacturing
  • Oversee and direct all jobs on the production floor with Manufacturing Supervisor
  • Perform a daily review of all documentation on the production floor for completeness
  • Ensure that all products are properly identified in all phases of manufacture
  • Perform other activities as assigned by management
  • Meet production deadlines in a dynamic manufacturing environment
  • Perform equipment and process validations as required
  • Identify discrepancies during manufacturing activities and notify Manufacturing Supervisor, and QA to ensure actions are taken in a timely manner to prevent deviations and non­ conformances due to incorrect documentation
  • Assist with other cross functional teams on an as needed basis to ensure company’s goals and objectives are met

EDUCATION AND QUALIFICATIONS:

Education Required

Bachelor’s Degree biology or chemistry is preferred; minimum of 3-4 years of college coursework in the sciences, or equivalent work experience is required

Experienced Required

3 – 4 years of experience in the pharmaceutical or related industry is preferred; experience with both paper and electronic systems preferred; experienced in basic word processing.

Specialized or Technical Knowledge, Licenses, or Certificates Needed

Knowledge of GMPs required. Aseptic manufacturing experience is strongly preferred. Must be a team player, willing to learn, and able to work flexible hours. Occasional heavy lifting up to 50lbs, standing, sitting, controlled hand movements, repetitive motions, some pushing and pulling.

YOUR REWARD:

  • Support scientists who are on the leading edge of immunotherapies for the treatment of cancer.
  • Earn a competitive salary that allows you to focus your attention on your passion.
  • A comprehensive benefits package including: medical, dental, vision, life and disability insurance, matching 401k, 10 paid holidays, and flexible PTO, plus stock options.

If this sounds like the right career to fit your personality and interests, please apply, we’re looking forward to meeting you!

*To apply, please visit: https://sorrentotherapeutics.bamboohr.com/jobs/view.php?id=228.

Sorrento Therapeutics, Inc. is an Equal Opportunity Employer

SPOTLIGHT: It was a busy year for Bioserv! We manufactured 29 different products that were used for studies in 8 countries around the world.