Careers
The Company strives to maintain a fulfilling working environment that includes open channels of communication, career development and opportunities for advancement.
OPK Biotech currently has openings due to the expansion of operations.
Please check back often for additional positions as they become available.
OPK Biotech is an Equal Opportunity Employer.
Current Openings:
Maintenance Mechanic
The Maintenance Mechanic will support Manufacturing utilities and other building support systems.Under limited supervision, will perform a variety of complex installation, preventative maintenance, troubleshooting and repair on line plant equipment.
Responsibilities include:
- Perform a variety of complex installation, preventative maintenance, and repair of all plant equipment such as lubrication, installation, and running adjustments.
- Locate and diagnose failures, replace defective components.
- Perform extensive troubleshooting using standard test equipment, drawings, sketches, specifications, and prints of electrical pneumatic.
- Work in accordance with all internal and external regulatory bodies including GMP, ICH, and OPK Biotech SOP’s.
- Locate and troubleshoot complex equipment failure including mechanical, electronic systems.
- Ensure timely corrective action for problems and issues related to equipment failure.
- Maintain maintenance, inventory and repair logs in compliance with cGMP and regulatory requirements
- Contact vendors and prepare purchase requisitions as required.
- Other duties and responsibilities as assigned coordinate and oversee repair and maintenance contractors.
Job requirements:
- High School graduate with additional experience in a field related to process and facilities operations.
- Must possess Massachusetts 2nd Fireman License or a Massachusetts trade license, i.e., electrician, carpenter, plumber, or HVAC and willing to get a Massachusetts 2nd Fireman License.
- Steam Engineer license and Waste Water Treatment (Industrial grade II,) experience is a plus
- Minimum of 2-6 years of related experience with cGMP and OSHA background.
- Must be proficient in troubleshooting pneumatic, electrical and mechanical failures.
- Must have strong working knowledge of chillers, building automation and security systems, pumps, mechanical seals and motors.
- General knowledge of shop tool operation and safety is required.
- Should have an in-depth knowledge of electrical plumbing, piping and the ability to read and understand complex drawings.
- Must be willing to be on our emergency call list.
- Will be required to perform confined space entry on a regular basis.
- Computer literacy beneficial
- Must be able to lift 30-40 lbs.
Manufacturing Supervisor
Manufacturing Supervisor oversees the day to day activities in the manufacturing environment to ensure effective use of materials, equipment and staff.
Responsibilities include:
- Demonstrate strong leadership attributes and provide work direction to staff
- Manage the performance of team members
- Operate complex systems and equipment in strict accordance with current GMPs, SOPs, and safety guidelines
- Serve as a technical resource focal point for questions and/or troubleshoting activities
- Train less experienced and/or new staff on new procedures
- Apply advanced concepts while performing the most complex tasks of this position
- Execute cross-training within the buffer preparation, purification, bio-reactor, CIP/SIP, and COP areas
- Review and approve DCRs
- Generate deviations and
- Communicate effectively with all departments supporting manufacturing operations (QA, regulatory, automation, maintenance and QC/micro)
Job requirements:
- Basic qualifications:
- Bachelor's Degree preferred.
- Must have prior experience in cGMP purification operations.
- This position also requires physical demands of lifting up to 50 pounds and may involve work with hazardous materials.
- Preferred Qualifications:
- Four plus years of cGMP purification operation experience.
- Candidates should also demonstrate good technical writing skills, strong troubleshooting skills, be familiar with biologics regulations and have previous experience with chromatography, MF/UF operations and project management.
- 1 to 2 years experience leading/supervising in a manufacturing environment preferred. Ideal candidates will have experience working with automated control systems.
Manufacturing Technician I
Manufacturing Technician I 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 to good aseptic practices
- Work in accordance with all internal and external regulatory guidelines and procedures
- Other duties and responsibilities as assigned
Job requirements:
- High School diploma or biotechnology certificate required.
- Able to work on assignments that are semi-routine in nature where the ability to recognize deviation from accepted practices is required.
- Able to receive general instructions on routine and non-routine assignments
- Able to lift 50 pounds
- Excellent oral and written communications skills
- Willing to work off-shifts and holidays as needed
QC Analyst III, Microbiology
The QC Analyst III, Microbiology, will provide support for manufacturing through environmental monitoring, water and steam testing. Performing routine and non-routine microbiology assays on raw materials, process intermediate, bulk and final product for release and stability.
Responsibilities Include:
- Environmental monitoring for controlled areas and during aseptic fills
- Able to gown aseptically for work in clean room environments
- Conduct microbiological assays, such as endotoxin, bioburden, biological indicator and microbial identification
- Maintain in-house microorganisms for growth promotion and enumeration
- Utility sampling as required (water, nitrogen, compressed air, EM)
- Conduct routine and non- routine product testing, including USP/EP bioburden testing, water testing,(bioburden,TOC,LAL)
- Conduct QC testing for raw materials, media and other lab supplies
- Maintain normal microbiology laboratory operations as required by written procedures
- Work on special projects (studies or validations) as assigned
- Testing responsibilities may include equipment and microbial test validation
- Ensure the laboratory equipment has been standardized, calibrated or monitored as appropriate for its application or function
- Should be a team player and also able to work independently
- Knowledge of cGMP/ICH Ph Eur. and FDA regulations
- Responsible for training other QC laboratory employee.
- Write up out-of-specification and out-of-trend reports and participate in laboratory investigation
- Initiate deviations and other associated documents when needed
- Review preliminary documentation
- Write, maintain SOPs/revisions
- Assist in trending water and EM for quarterly and annual review
- Other duties and responsibilities as assigned
- Work overtime when needed
Job Requirements:
- 5+ years experience in Biotechnology / Pharmaceutical Microbiology.
- A strong background in Microbiological techniques and theory desired.
- Multi-task and detail-oriented.
- Some travel may be required during production runs to support our Pennsylvania facility.
- Data analysis and statistical skill would be a plus.
- Able to function in a fast-paced team oriented environment, and communicate effectively.
- Minimum a Bachelors degree in a scientific field of study preferable but not required.
- Proficient with computers (Microsoft Word, Excel, and Access).
- Able to lift 50 lbs
QC Supervisor Weekend Night Shift
The QC Supervisor, Weekend Night Shift, provides supervision of the weekend night operations for Quality Control in our Cambridge facilities. This position reports to the QC Manager.
Responsibilities Include:
- Maintain QC analytical function in GMP compliance and regulatory inspection ready.
- Supervise all aspect 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.
- Participate in validation of equipment and analytical assays.
- Assist in the conduct of laboratory investigations.
- Conduct periodic reviews of standard operating procedures for adequacy and compliance with current versions of compendia.
- Host internal audits of QC labs
- Ensure maintenance of analytical equipment maintenance and calibration logs
Job Requirements:
- Bachelors or Masters degree in related field.
- 3 – 4 years experience in Quality Control.
- Working knowledge of standard analytical methods and equipment.
- Excellent interpersonal skills including oral and written communications
- Broad knowledge of analytical procedures common in the biotech community.
- Solid management skills
- Some experience in Quality Assurance is a plus
- Proficient in MSOffice Suite and Standard QC databases
- Able to lift 30 lbs.
QC Supervisor, Weekend Day Shift
The QC Supervisor, Weekend Day Shift provides supervision and support for the weekend quality control staff, and reports to the Manager of Quality here in our Cambridge facilities.
Responsibilities include:
- Maintain QC analytical function in GMP compliance and regulatory inspection ready
- Supervise all aspects of testing in support of first shift manufacturing operations and facility environmental monitoring
- Ensure that all testing is conducted in accordance with established test methods and/or USP or Ph Eur.
- Participate in validation of equipment and analytical assays
- Assist in the conduct of laboratory investigations
- Conduct periodic reviews of standard operating procedures for adequacy and compliance with current versions of compendia
- Host internal audits of QC labs
- Ensure maintenance of analytical equipment maintenance and calibration logs
Job requirements:
- 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
- Good oral and written communication skills
- Broad knowledge of analytical procedures common in the biotech community
- Solid management skills
- Some experience in Quality Assurance a plus.
- Proficient in MSOffice and standard QC data bases.
- Able to lift up to 30 lbs.
QC Supervisor, Third Shift
The QC Supervisor Third Shift provides supervision of QC lab operations in our Cambridge facilities. This position reports to the Manager of Quality.
Responsibilities include:
- Maintain QC analytical function in GMP compliance and regulatory inspection ready
- Supervise all aspects of testing in support of first shift manufacturing operations and facility environmental monitoring
- Ensure that all testing is conducted in accordance with established test methods and/or USP or Ph Eur.
- Participate in validation of equipment and analytical assays
- Assist in conducting of laboratory investigations
- Conduct periodic reviews of SOPs for adequacy and compliance with current versions of compendia.
- Host internal audits of QC labs
- Ensure maintenance of analytical equipment and calibration logs
Job requirements:
- Bachelors or Masters degree in a scientific field.
- 3 – 4 years experience in QC
- Working knowledge of standard analytical methods and equipment
- Excellent interpersonal skills
- Good oral and written communication skills
- Broad knowledge of analytical procedures common in the biotech community
- Solid management skills
- Some experience in QA a plus
- Proficient in Microsoft Office Suite and standard QC data bases
- Able to lift up to 30 lbs.
QC Supervisor, First Shift
The QC Supervisor First Shift provides supervision of first shift Quality operations in our Cambridge lab. The QC Supervisor reports to the Manager of Quality.
Responsibilities include:
- Maintain QC analytical function in GMP compliance and regulatory inspection ready
- Supervise all aspect of testing in support of first shift manufacturing operations and facility environmental monitoring
- Ensure that all testing is conducted in accordance with established test methods and/or USP or Ph Eur.
- Participate in validation of equipment and analytical assays
- Assist in conducting laboratory investigations
- Conduct periodic reviews of SOPs for adequacy and compliance with current versions of compendia
- Host internal audits of QC labs
- Ensure maintenance of analytical equipment maintenance and calibration logs
Job requirements:
- Bachelors or Masters Degree in a scientific field
- 3 – 4 years experience in QC
- Working knowledge of standard analytical methods and equipment
- Excellent interpersonal skills
- Good oral and written communication skills
- Broad knowledge of analytical procedures common in the biotech community
- Solid management skills
- Able to lift up to 30 lbs
- Previous experience in QA preferred
- Proficient in MS Office Suite and standard QC data bases is required
QC Analyst I, Third Shift
TThe QC Analyst I Third Shift will ensure the QC laboratories have adequate personnel throughout the third shift of operations in our Cambridge facilities.
Responsibilities include:
- Work within OPK’s Quality System and cGMP/ICH guidelines for manufacturing for large volume parenterals
- Followiwritten SOPs for routine and non-routine testing of in-process samples, API and drug product and raw materials and stability samples
- Utility and environmental systems sampling and testing and data and documents review.
- Assist with general maintenance of QC laboratory and calibration and maintenance of analytical equipment
- Maintain QC trending databases
- Work within OPK's environmental Health and Safety policies.
- May be required to participate in optimization and validation of analytical methods
Job requirements:
- Bachelors Degree in a scientific field preferred
- 0 – 2 years experience in a GMP type facility preferred
- Proficient in use of computers and MS Office Suite
- Able to lift up to 50 lbs
QC Supervisor, Weekend Night Shift
The QC Supervisor, Weekend Night Shift, will be responsible for supervising the night operations for Quality Control in our Cambridge facilities.
Responsibilities include:
- Maintain QC analytical function in GMP compliance and regulatory inspection ready
- Supervise all aspect of testing in support of first shift manufacturing operations and facility environmental monitoring
- Utility and environmental systems sampling and testing and data and documents review.
- Ensuring that all testing is conducted in accordance established test methods and/or USP or Ph Eur.
- Assisting in the conduct of laboratory investigations.
- Ensure maintenance of analytical equipment maintenance and calibration logs
- Conduct periodic reviews of standard operating procedures for adequacy and compliance with current versions of compendia
- Host internal audits of QC labs
Job requirements:
- Bachelors or Masters degree in a scientific field required
- 3 – 4 years experience in QC
- Working knowledge of standard analytical methods and equipment
- Excellent interpersonal skills
- Good oral and written communication skills
- Broad knowledge of analytical procedures common in the biotech community.
- Host internal audits of QC labs
- Solid management skills
- Some experience in QA a plus
- Proficient in MSOffice and Standard QC databases.
- Able to lift up 30 lbs.
QA Specialist, Training and Compliance
The QA Specialist, Training and Compliance, will develop, coordinate, implement, oversee and maintain an effective, robust training program for varied levels of the company. In addition, the Quality Assurance Specialist will actively search, creatively design and implement effective methods to educate, enhance performance and recognize performance.
Responsibilities include:
- Develop and build curriculum and materials for company training course (presentations, handouts, visual aids, etc)
- Schedule and conduct training program
- Evaluate training delivery, measure results, and recommend changes to company training programs
- Assist with managing and monitoring high-level leadership and career development programs GXP and Quality Systems Training
- Establish training curricula, assessment and evaluation guidelines
- Word process SOPs and batch records
- Track documents throughout review/approval process
- Master and distribute effective documents
- Maintain vendor files
- Audit SOP books
- Process P/N requests and maintain P/N list/files
- Copy and issue production records for manufacturing
- Sort, Reconcile and File Oxyglobin product distribution records
- Maintain QA databases, including documentation and training records
- Compile and Issue periodic reports/status updates for various systems
- Batch record review and disposition
- Support QC environmental monitoring program and trending
- Support internal audit activities
Job requirements:
- Bachelors degree with 2 – 4 years of experience in pharmaceutical industry and administrative support role is required. Higher education desirable
- 2-3 years of Quality pharmaceutical or biopharmaceutical industry experience and strong interpersonal and communication skills
- Experience creating SOPs, presenting data and reports, auditing and reviewing critical documents, such as validation reports and clinical study reports, required
- Working knowledge of cGMPs and their application to a wide variety of problems and situations to ensure compliance with regulations and applicable internal standards
- Experience working in document control group in a regulated industry, preferable biotech industry and experience with FDA regulations/cGMPs a plus
- Data entry, proof-reading and technical writing skills
- Attention to detail and good communication skills
- Computer experience – MS Word required, MS Excel and Access highly desirable
- Able to lift up to 20-30 lbs
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.
