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.
Current Openings:
QC Manager
The Quality Control Manager will be responsible for overall management of QC analytical function for Cambridge facility and reports to the Senior Director of Quality.
Responsibilities include:
- Maintain QC analytical function in GMP compliance and regulatory inspection ready
- Manage QC analytical testing of raw material, in-process, bulk and final API and drug product formulations
- Ensure that all testing is conducted in accordance with established test methods and/or USP or Ph Eur.
- Oversee validation of equipment and analytical assays
- Manage special projects that may require other inter-departmental involvement
- Make recommendations for corrective action necessary to assure conformity with quality specifications
- Conduct laboratory investigations in response to OOS
- Support QA during regulatory inspections
- Support the transformation of the existing validation program to a science and risk-based verification program founded in Quality Risk Management and ASTM E2500 principles
Job requirements:
- 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
- Proven project management skills specific to analytical laboratory operations
- Able 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
- Ensure and adhere to budgets, schedules and performance requirements
- Excellent interpersonal skills in order to interact regularly with both senior level managers and staff
- Good oral and written communication skills
- Able to 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
- Able to lift 30 lbs
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
Senior Controls Engineer
The Sr. Controls Engineer is responsible for Programmable Logic Controller (PLC) systems and subsystems at our facilities. Additional equipment responsibilities would include operator interface (HMI) systems associated with PLCs and single/multiloop controllers.
Responsibilities Include:
- Maintain all Allen Bradley and Siemens PLC Systems
- Evaluate, troubleshoot and repair all hardware associated within associated PLC systems
- Evaluate, troubleshoot and develop software solutions within associated PLC systems
- Maintain proper test and technical related documentation and perform all work according to OPK Biotech SOPs and regulatory guidelines as required in a cGMP environment
- Maintain batch production plant automation systems regarding evaluation, troubleshooting and repair of all hardware and software related issues
- Lead engineering activities in support of future projects and, as required, support process control investigations in manufacturing
- Assist in validation efforts required for maintaining validated status of existing equipment/processes and qualification of new equipment/processes
Job Requirements:
- Bachelors degree in Mechanical, Electrical, or Chemical Engineering, Computer Sciences, or equivalent
- 4-6 years experience with various makes of PLCs to include: Modicon, Allen Bradley, Siemens and others
- Proficiency must be demonstrated with associated development software tools as well as hardware configuration
- Able to communicate technical thoughts clearly
- Proficient with field instrumentation, a high level of electronics literacy and knowledge of most Microsoft products is required
- 24-hour on-call status
- Able to work on multiple projects at a time and willing to work off-shift if necessary to complete projects
- Experience with preparing for and participating in regulatory inspections
- Self-starter with the ability to work independently as well in a team with excellent interpersonal and verbal and written communication skills
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.
Automation and Controls Engineer - Souderton, PA
The Controls Engineer will be responsible for maintaining and operating plant automation systems, DCS batching and PLC skid systems, operator interfaces, PI plant historian, BMS and subsystems at the Souderton, Pennsylvania facility.
This position will provide automation engineering support for the manufacture, development and process optimization for the batch production of an intermediate hemoglobin based oxygen solution.
This well-rounded position allows the Engineer to be involved in all aspects of an automated biotech batch facility and to support the manufacturing process (CIP/SIP, validation, start-up, production, monitoring, etc).
Responsibilities include:
- Maintain batch production plant automation systems regarding evaluation, troubleshooting and repair of all hardware and software related issues
- Assist in validation efforts required for maintaining validated status of existing equipment/processes and qualification of new equipment/processes
- Provide engineering support for troubleshooting and problem solving manufacturing equipment and processes
- Maintain proper test and technical related documentation and perform all work according to OPK Biotech SOPs and regulatory guidelines (cGMPs)
- Lead engineering activities in support of future projects and, as required, support process control investigations in manufacturing
Job requirements:
- Bachelors degree in Engineering (Chemical, Electrical, Biochemical, Mechanical, Computer Science)
- 5-10 years experience with various automated or programmable systems, Allen Bradley PLC, Distributed Control Systems DCS (Batch Experience preferred) and BMS Building Management Systems
- 5+ years relevant experience in engineering, biotechnology or pharmaceutical applications or corporations that support the biopharmaceutical industries.
- Proficient with field instrumentation, a high level of electronics literacy and knowledge of most Microsoft products is required
- Able to work on multiple projects at a time and willing to work off shift if necessary to complete projects
- Experience with preparing for and participating in regulatory inspections
- Self starter with the ability to work independently as well in a team with excellent interpersonal and written and verbal communication skills
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 Analyst II Second Shift
The QC Analyst II, Second Shift will provide support for manufacturing through routine and non-routine environmental testing, as well as raw materials testing. The ability to function in a fast-paced team environment and communicate effectively is essential.
Responsibilities include:
- Work within OPKs Quality System and cGMP/ICH guidelines for manufacturing of large volume parenterals
- Follow written standard operating procedures for routine and non-routine testing of in-process samples, API and drug product, as well as raw materials and stability samples
- Sample, test and date utility and environmental systems and documents review
- Assist in general maintenance of QC laboratory - calibration and maintenance of analytical equipment
- Test raw materials, according to PH Eur and USP monographs
- Assist with preparing department for regulatory inspections
- Write SOPs and test methods to support laboratory operations.
- Maintain QC trending data bases
- Work with OPK’s environmental health and safety policies
- Participate in optimization and validation of analytical methods
Job requirements:
- Bachelors Degree in science preferred
- 2-5 years in a GMP type facility required
- Proficient in Microsoft Office Suite, as well as a working knowledge of HPLC (preferably Waters Empower and Millenium software)
- Good oral and written communication skills
- Able to work both independently and in a team environment
- Able to lift up to 50 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 Lead Specialist III
The QA Lead Specialist III will implement and maintain QA policies in support of manufacturing operations to ensure compliance with OPK's Quality Systems and domestic and international cGMP regulations and guidelines.
Responsibilities include:
- Report to the QA manager
- Batch review and disposition
- Oversee maintenance of deviations investigations and corrective actions database
- Manage QA release of raw materials
- Assist QA management with compilation of annual quality report
- Participate in supplier qualification and audits
- Work with documentation to facilitate periodic review of SOPs
- Conduct internal and external audits
- Author investigation reports for OOS and tracks effectiveness of corrective actions
- Manage or support management of stability program
Job requirements:
- Bachelors or Masters degree in a scientific field preferred.
- 4-6 years experience working in QA/QC in a pharmaceutical, biopharmaceutical or clinical study environment
- Strong interpersonal and communications skills
- Experience creating SOPs, presenting data and reports, auditing and reviewing critical documents such as validation reports and clinical study reports required
- Comprehensive understanding of cGMPs and their application to a wide valriety of problems and situations to ensure compilance with regulations and applicable internal standards
- Proficient in MSOffice Suite
- Able to lift up to 50 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.
