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The Company - OPK Biotech - Developing, Manufacturing, Marketing Oxygen therapeutics

Careers

OPK Biotech LLC is expanding its operations. Please check back often for additional positions as they become available. The Company strives to maintain a fulfilling working environment that includes open channels of communication, career development and opportunities for advancement.

OPK Biotech LLC is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, national origin, religion, age, disability, or status as a Protected Veteran.

Current Openings: Camridge MA

Current Openings: Souderton PA

Sr. Regulatory CMC Associate

The Sr. Regulatory CMC Associate will play a lead role in driving the CMC portion of regulatory filings including coordination, review and timely generation of submission ready documents. This position is based in Cambridge and reports to the Director of Regulatory and Clinical Operations.

Responsibilities include:

  • Play the lead role in managing post-approval changes, including change management across products, and coordinating all CMC aspects of regulatory submissions
  • Ensure all CMC dossier data remain relevant, compliant, and an accurate reflection of all processes and practices.
  • Ensure the content and format of regulatory CMC submissions comply with applicable regulations and guidelines.
  • Identify and assess regulatory risks for specific projects.
  • Participate in the design, development and implementation of department improvement initiatives.
  • Research, review and interpret the regulatory environment surrounding related to product approvals, current guidance documents to support the development of optimal regulatory strategies that support successful submissions.
  • Coordinate cross functional department requirements to ensure regulatory timelines and milestones are met.

Job requirements:

  • BA/BS in a scientific discipline.
  • 6+ years hands on regulatory CMC experience, (biologics preferred) or 3 years pharmaceutical manufacturing, QC, and/or QA, with 3 years regulatory CMC.
  • Experience in the preparation of CMC regulatory documents for major submissions (CTD, BLA, MAA, supplements, variations, responses)
  • Thorough knowledge of US & EU regulatory requirements pertaining to the manufacture of pharmaceutical and sterile biological APIs and drug products.
  • Must be able to write and verbally communicate information in a clear and concise manner.
  • Excellent interpersonal skills and an ability to represent the Company to outside parties as required.
  • Strong organizational skills, including the ability to prioritize workload, and an ability to work in a high pressure environment.
  • Effective cross functional and cross cultural skills.
  • Intermediate / advanced Microsoft Office

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QC Supervisor 1st and 3rd shifts

The QC Supervisor oversees development and implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products. Oversees and coordinates shift activities of the QC Lab.

Responsibilities include:

  • Maintains QC analytical function in GMP compliance and regulatory inspection ready.
  • Supervises all aspects of testing in support of first shift manufacturing operations and facility environmental monitoring.
  • Ensure that all testing is conducted in accordance established test methods and/or USP or Ph Eur.
  • Participates in validation of equipment and analytical assays.
  • Assists in the conduct of laboratory investigations.
  • Conducts periodic reviews of standard operating procedures for adequacy and compliance with current versions of compendia.
  • Hosts internal audits of QC labs.
  • Ensures maintenance of analytical equipment maintenance and calibration logs

Job requirements:

  • This job requires a bachelors or masters degree in a scientific field.
  • 3 – 4 years experience in Quality Control.
  • Working knowledge of standard analytical methods and equipment.
  • Excellent interpersonal skills and good oral and written communication skills
  • Broad knowledge of analytical procedures common in the biotech community.
  • Some experience in Quality Assurance is a plus
  • Proficient in MSOffice and standard QC data bases

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Quality Control Manager

The Quality Control Manager will be responsible for overall management of QC Analytical function for OPK Biotech’s Cambridge-based facility.

Responsibilities include:

  • Maintains QC analytical function in GMP compliance and regulatory inspection ready
  • Manages QC Analytical testing of raw material, in-process, bulk and final API and drug product formulations
  • Ensures that all testing is conducted in accordance established test methods and/or USP or Ph Eur.
  • Oversees validation of equipment and analytical assays.
  • Manages special projects that may require other interdepartmental involvement.
  • Makes recommendations for corrective action necessary to assure conformity with quality specifications.
  • Conducts laboratory investigations in response to OOS
  • Supports QA during regulatory inspections 

Job requirements:

  • Requires a Bachelors or Masters degree or equivalent and a minimum of 10 years experience with a Bachelors or 3 - 7 years experience with a Masters degree and proven project management skills specific to analytical laboratory operations.
  • Proven project management skills in a laboratory environment.
  • Ability to work and solve complex problems and exercise independent judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
  • Ability to ensure and adhere to budgets, schedules and performance requirements.
  • Excellent interpersonal skills in order to regularly interact with both senior level managers and staff. 
  • Good oral and written communication skills and should exercise tact and diplomacy in sensitive situations.
  • Broad knowledge of analytical procedures common in the biotech industry
  • Some experience in Quality Assurance a plus
  • Proficient in MSOffice and standard QC data bases
  • Lifting up to 30 lbs.

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 Manufacturing Technician

The Manufacturing Technician is responsible for performing all manufacturing operational activities including Separation, Purification, and Final Bulk processing using standard operating procedures in a cGMP environment.

Responsibilities include:

  • Operate and maintain process equipment
  • Perform CIP/SIP/COP activities
  • Weigh and formulate large scale buffers
  • Document activity logs, checklists, and batch records
  • Work in a clean room environment and comply with good aseptic practices
  • Work in accordance with all internal and external regulatory guidelines and procedures
  • Maintain warehouse
  • Other duties and responsibilities as assigned

Job requirements:

  • High School diploma or Biotechnology certificate required
  • The ability to work on assignments that are semi-routine in nature where the ability to recognize deviation from accepted practices is required 
  • Good communications skills, both written and oral
  • The ability to safely move or lift 50 pounds without additional 
  • Willing to work off shifts and holidays as needed. 
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Maintenance Mechanic

The Maintenance Mechanic supports manufacturing utilities and other building support systems. Under limited supervision, performs a variety of complex installation, preventative maintenance, troubleshooting, and repair of on- line plant equipment.

Responsibilities include:

  • Perform safely a variety of complex installation, preventative, and predictive maintenance on process and utilities systems
  • Complete and document properly work orders in accordance with OPK Biotech’s system
  • Perform daily equipment checks, maintain logs, monitor facilities operations and equipment
  • Maintain, monitor and operate safely high purity water, clean steam, compressed air, generators, chilled and glycol systems
  • Maintain clean rooms, HVAC, building management systems, high pressure steam, WFI, RODI, and process equipment
  • Assist in establishing and maintaining inventory of spare parts and supplies
  • Work with service contractors and vendors as required
  • Respond to emergencies 24/7
  • Troubleshoot complex equipment and utility problems
  • Respond promptly to alarms

Job requirements:

  • Must possess Massachusetts State 2nd Fireman License
  • High school graduate with additional training experience in a field related to process and facilities operations
  • Massachusetts Waste Water Treatment experience is a plus
  • A good understanding of equipment, facility operation, and maintenance requirements for a GMP facility
  • Attention to detail and excellent communications skills, both written and oral
  • Must be willing to work all shifts, including weekends
  • Computer proficiency, MS Office, is a plus
  • Must be able to lift 30-40 pounds
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 Souderton PA - Manufacturing Technician

The Manufacturing Technician is responsible for performing all functions to produce an intermediate bovine blood-derived product, using standard operating procedures in a cGMP environment.

Responsibilities include:

  • Assemble, clean and operate pharmaceutical manufacturing equipment
  • Document all work, according to cGMP practices.
  • Perform all work using an automated control system or manual operations in compliance with SOPs and cGMPs.
  • Maintain clean room environment, according to regulatory requirements.
  • Monitor and assist with blood collection process.
  • Other duties and responsibilities as assigned

Job requirements:

  • HS diploma or Biotechnology certificate required; BS preferred.
  • 1+ years experience in pharmaceutical, chemical, and/or biological manufacturing and cGMP environment.
  • Excellent communications skills
  • Experience with MS Office
  • The ability to safely move or lift 40-50 pounds without additional. 
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Please fax, email, or mail to: 

Human Resources
OPK Biotech LLC
11 Hurley Street,
Cambridge, MA 02141
Fax: 617.234.6507
Email:   hr@opkbiotech.com

OPK Biotech is an Equal Opportunity Employer.

HBOCLAB.com

is a Resource Guide for individuals interested in the impact of OPK Biotech LLC's Hemoglobin Based Oxygen Carriers (HBOCs) on laboratory assays. The information presented for Hemopure® also applies to Oxyglobin®.

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