Lab Supervisor
General InformationCountry United States City Irvine, California Functional Area Research & Development Job Group Analytics Employment Type Permanent Contract Working time Full-time At its locations around the world, Siegfried offers employees exciting career opportunities in international settings.
We cultivate multidisciplinary cooperation and encourage our staff to actively shape and influence their careers.
This approach, coupled with our dynamic working environment, make Siegfried an attractive employer.
Your role Scope and Purpose of PositionManage quality control activities related to biology and microbiology testing for all product lines.
Supervise the microbiology lab staff.
Responsibilities1.
Develop and improve analytical test methods for incoming material, in-process and final product release.
2.
Develop quality control standards3.
Collaborate with QA to develop and finalize testing requirement and specification for incoming material, in process and final product release criteria.
4.
Identify process and quality problem, recommend solutions, develop or recommend process improvements, and assist implementation in Production5.
Interact with contract test laboratories in development of off-site test methods6.
Interact with customer on contract test services provided by the microbiology laboratories.
7.
Oversee and delegate the necessary testing in the microbiology and biology8.
Review and verify analytical test results from both in-house and contract laboratories.
9.
Collaborate with Business Development technical group in transfer of new products, processes and test methods from customer.
10.
Perform the gap analysis of the test methods provided by customers against Siegfried's requirement.
11.
Write, revise, review and approve documentation related to test method validation/verification, stability, and chemistry testing and laboratories activities.
12.
Write test method verification/validation protocols, perform or supervise testing, and write final verification validation reports.
13.
Manage stability program for internal and customer project, write protocol and report for product stability project, manage the stability database for stability time point, stability inventory and also manage the availability of the stability chambers.
14.
Support Cleaning Validation Program15.
Acquire and qualify new equipment for testing of Biologics, Protein and DNA products.
16.
Support all regulatory submissions of the customers.
17.
Support regulatory inspection and customer audit activities.
18.
Provide leadership, development and direction to the microbiology lab staff19.
Support the hiring of Laboratories staff that is technically capable to carry out the related job duties.
20.
All other duties assigned by the immediate supervisor.
Your profile Required Knowledge, Skills and Abilities Strong skills dealing with the FDA and ISO agencies Ability to be involved in all related audits Understand the GMP requirement for medical device/pharmaceutical industry, with quality control/compliance background.
Excellent knowledge of analytical test methodologies and stability studies.
Strong technical and problem-solving skills.
Ability to coordinate multiple responsibilities and activities simultaneously.
Experience leading or supervising a team Must have strong communication, leadership, and interpersonal skills.
Must be comfortable working in a dynamic environment with changing priorities Required Education and Experience Bachelor or Advance Degree in Microbiology or Chemistry 3-5 years of related experience 3
year leading and or supervising a team Working at Siegfried Siegfried's work environment is dynamic and international.
With a highly professional and motivated team, the company operates in a future-oriented business field.
Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage.
Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance.
We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company.
The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites.
Additional conditions of employment are governed by location-specific circumstances, legislation and customs.
Who we are In the Midst of People's Lives - Across the Globe The Siegfried Group is one of the world's leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms.
As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model.
The Siegfried name stands for highest quality, efficiency, flexibility and safety.
Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations.
For them we develop and produce product innovations on a large scale to finished products.
We integrate our offer seamlessly into the customers' value chain.
Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production.
We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine.
Moreover, we produce 20 percent of global demand for caffeine.
Consequently, nearly 1 billion individuals come into contact with Siegfried products.
What we do in Irvine Irvine is one of Siegfried's sterile drug product manufacturing sites, providing contract development and manufacturing services (CDMO) specializing in difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices.
Main activities Provides cGMP sterile drug product fill finish of biologics, suspensions, emulsions, ointments, and gels All fully cGMP and SHE compliant Features Commercial Products:
5 automated filling lines, Commercial manufacturing, Batch sizes up to 150 K units, Fill Volumes 0.
5 ml - 100 ml Semi-automated and automated visual inspection Automated packaging with digital data visual verification Stability study services Drug delivery Laboratory services Clinical Products small lot capability (semi-automated filling, batch sizes up to 5 K units) Clinical manufacturing (batch sizes less than 5 K units) Strategic importance CDMO for innovative and difficult-to-manufacture products from clinical to commercial NDA and ANDA products Provides contract sterile drug product manufacturing and laboratory services to the pharmaceutical and biotechnology industries < Back to job list Recommended Skills Analytical Auditing Biology Business Development Business Process Improvement Communication Estimated Salary: $20 to $28 per hour based on qualifications.
We cultivate multidisciplinary cooperation and encourage our staff to actively shape and influence their careers.
This approach, coupled with our dynamic working environment, make Siegfried an attractive employer.
Your role Scope and Purpose of PositionManage quality control activities related to biology and microbiology testing for all product lines.
Supervise the microbiology lab staff.
Responsibilities1.
Develop and improve analytical test methods for incoming material, in-process and final product release.
2.
Develop quality control standards3.
Collaborate with QA to develop and finalize testing requirement and specification for incoming material, in process and final product release criteria.
4.
Identify process and quality problem, recommend solutions, develop or recommend process improvements, and assist implementation in Production5.
Interact with contract test laboratories in development of off-site test methods6.
Interact with customer on contract test services provided by the microbiology laboratories.
7.
Oversee and delegate the necessary testing in the microbiology and biology8.
Review and verify analytical test results from both in-house and contract laboratories.
9.
Collaborate with Business Development technical group in transfer of new products, processes and test methods from customer.
10.
Perform the gap analysis of the test methods provided by customers against Siegfried's requirement.
11.
Write, revise, review and approve documentation related to test method validation/verification, stability, and chemistry testing and laboratories activities.
12.
Write test method verification/validation protocols, perform or supervise testing, and write final verification validation reports.
13.
Manage stability program for internal and customer project, write protocol and report for product stability project, manage the stability database for stability time point, stability inventory and also manage the availability of the stability chambers.
14.
Support Cleaning Validation Program15.
Acquire and qualify new equipment for testing of Biologics, Protein and DNA products.
16.
Support all regulatory submissions of the customers.
17.
Support regulatory inspection and customer audit activities.
18.
Provide leadership, development and direction to the microbiology lab staff19.
Support the hiring of Laboratories staff that is technically capable to carry out the related job duties.
20.
All other duties assigned by the immediate supervisor.
Your profile Required Knowledge, Skills and Abilities Strong skills dealing with the FDA and ISO agencies Ability to be involved in all related audits Understand the GMP requirement for medical device/pharmaceutical industry, with quality control/compliance background.
Excellent knowledge of analytical test methodologies and stability studies.
Strong technical and problem-solving skills.
Ability to coordinate multiple responsibilities and activities simultaneously.
Experience leading or supervising a team Must have strong communication, leadership, and interpersonal skills.
Must be comfortable working in a dynamic environment with changing priorities Required Education and Experience Bachelor or Advance Degree in Microbiology or Chemistry 3-5 years of related experience 3
year leading and or supervising a team Working at Siegfried Siegfried's work environment is dynamic and international.
With a highly professional and motivated team, the company operates in a future-oriented business field.
Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage.
Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance.
We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company.
The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites.
Additional conditions of employment are governed by location-specific circumstances, legislation and customs.
Who we are In the Midst of People's Lives - Across the Globe The Siegfried Group is one of the world's leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms.
As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model.
The Siegfried name stands for highest quality, efficiency, flexibility and safety.
Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations.
For them we develop and produce product innovations on a large scale to finished products.
We integrate our offer seamlessly into the customers' value chain.
Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production.
We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine.
Moreover, we produce 20 percent of global demand for caffeine.
Consequently, nearly 1 billion individuals come into contact with Siegfried products.
What we do in Irvine Irvine is one of Siegfried's sterile drug product manufacturing sites, providing contract development and manufacturing services (CDMO) specializing in difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices.
Main activities Provides cGMP sterile drug product fill finish of biologics, suspensions, emulsions, ointments, and gels All fully cGMP and SHE compliant Features Commercial Products:
5 automated filling lines, Commercial manufacturing, Batch sizes up to 150 K units, Fill Volumes 0.
5 ml - 100 ml Semi-automated and automated visual inspection Automated packaging with digital data visual verification Stability study services Drug delivery Laboratory services Clinical Products small lot capability (semi-automated filling, batch sizes up to 5 K units) Clinical manufacturing (batch sizes less than 5 K units) Strategic importance CDMO for innovative and difficult-to-manufacture products from clinical to commercial NDA and ANDA products Provides contract sterile drug product manufacturing and laboratory services to the pharmaceutical and biotechnology industries < Back to job list Recommended Skills Analytical Auditing Biology Business Development Business Process Improvement Communication Estimated Salary: $20 to $28 per hour based on qualifications.
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