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Posted : Friday, August 30, 2024 03:29 PM
Job Title: Microbiology and Environmental Monitoring Laboratory Manager
About Ocyonbio:
Ocyonbio is a biotechnology company based in Aguadilla, Puerto Rico, dedicated to propelling the future of healthcare.
We provide cGMP spaces that can be customized to meet unique requirements and services to help catalyze the development, manufacturing, and commercialization of biologics, genetic, and cellular therapies.
We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications.
We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued.
The character of our employees is as important as their talent, and we are proud of the team and environment we are assembling as we grow.
Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.
R.
00603 Job Overview: We are looking for a dedicated and experienced Microbiology Laboratory Manager to lead our microbiology team.
The successful candidate will design and start up the Microbiology Laboratory and manage the day-to-day testing operations, ensuring the delivery of high-quality analytical services and compliance with regulatory standards and company policies.
Key Responsibilities: Oversee and manage all aspects of microbiology laboratory operations, including personnel, equipment, supplies, and procedures.
Ensure compliance with relevant regulations (e.
g.
, FDA, EMA, ICH) and internal company policies and procedures.
Develop and validate microbiological testing methods for raw materials, in-process materials, and finished products.
Develop and implement Environmental Monitoring Program.
Conduct trend analyses of environmental monitoring, in-process, and release data to support continuous improvement.
Manage the investigation of out-of-specification (OOS) and out-of-trend (OOT) results, deviations, and non-conformances.
Provide technical guidance and training to laboratory staff and ensure that all employees adhere to safety regulations.
Review and approve laboratory data, reports, and documents.
Participate in regulatory, internal, and external audits.
Qualifications: A Master's or Ph.
D.
degree in Microbiology or a related field.
A minimum of 8 years of experience in a microbiology laboratory within the pharmaceutical or biopharmaceutical industry, with at least 5 years in a managerial role.
Comprehensive knowledge of microbiological testing methods, method validation, aseptic techniques, and sterility assurance.
Strong knowledge of parenteral manufacturing activities and PDA guidelines.
Experience with Master Control and LIMS.
Familiarity with regulatory standards, including FDA, EMA, and ICH guidelines.
Strong leadership, team management, and interpersonal skills.
Excellent written and verbal communication skills.
Detail-oriented with strong problem-solving abilities.
What we offer: • Competitive salary (DOE (Design of Experiments).
) • Health, dental, and vision benefits.
• Professional training and development opportunities.
• Opportunities to participate in the company stock options program Working conditions: Physical Requirements OFFICE POSITION - While performing the duties of this job the employee is required to: Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment.
Specific vision abilities required by this job include close vision requirements due to computer work.
Light to moderate lifting is required.
Moderate noise (i.
e.
, business office with computers, phones, printers, traffic light).
Ability to sit at a computer terminal for an extended period.
Sedentary work Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body.
Sedentary work involves sitting most of the time.
Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
We are an Equal Opportunity Employer Ocyonbio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
To learn more about us, please visit our website: https://ocyonbio.
com
We provide cGMP spaces that can be customized to meet unique requirements and services to help catalyze the development, manufacturing, and commercialization of biologics, genetic, and cellular therapies.
We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications.
We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued.
The character of our employees is as important as their talent, and we are proud of the team and environment we are assembling as we grow.
Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.
R.
00603 Job Overview: We are looking for a dedicated and experienced Microbiology Laboratory Manager to lead our microbiology team.
The successful candidate will design and start up the Microbiology Laboratory and manage the day-to-day testing operations, ensuring the delivery of high-quality analytical services and compliance with regulatory standards and company policies.
Key Responsibilities: Oversee and manage all aspects of microbiology laboratory operations, including personnel, equipment, supplies, and procedures.
Ensure compliance with relevant regulations (e.
g.
, FDA, EMA, ICH) and internal company policies and procedures.
Develop and validate microbiological testing methods for raw materials, in-process materials, and finished products.
Develop and implement Environmental Monitoring Program.
Conduct trend analyses of environmental monitoring, in-process, and release data to support continuous improvement.
Manage the investigation of out-of-specification (OOS) and out-of-trend (OOT) results, deviations, and non-conformances.
Provide technical guidance and training to laboratory staff and ensure that all employees adhere to safety regulations.
Review and approve laboratory data, reports, and documents.
Participate in regulatory, internal, and external audits.
Qualifications: A Master's or Ph.
D.
degree in Microbiology or a related field.
A minimum of 8 years of experience in a microbiology laboratory within the pharmaceutical or biopharmaceutical industry, with at least 5 years in a managerial role.
Comprehensive knowledge of microbiological testing methods, method validation, aseptic techniques, and sterility assurance.
Strong knowledge of parenteral manufacturing activities and PDA guidelines.
Experience with Master Control and LIMS.
Familiarity with regulatory standards, including FDA, EMA, and ICH guidelines.
Strong leadership, team management, and interpersonal skills.
Excellent written and verbal communication skills.
Detail-oriented with strong problem-solving abilities.
What we offer: • Competitive salary (DOE (Design of Experiments).
) • Health, dental, and vision benefits.
• Professional training and development opportunities.
• Opportunities to participate in the company stock options program Working conditions: Physical Requirements OFFICE POSITION - While performing the duties of this job the employee is required to: Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment.
Specific vision abilities required by this job include close vision requirements due to computer work.
Light to moderate lifting is required.
Moderate noise (i.
e.
, business office with computers, phones, printers, traffic light).
Ability to sit at a computer terminal for an extended period.
Sedentary work Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body.
Sedentary work involves sitting most of the time.
Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
We are an Equal Opportunity Employer Ocyonbio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
To learn more about us, please visit our website: https://ocyonbio.
com
• Phone : NA
• Location : Aguadilla, PR
• Post ID: 9004083669
