Biopharma Production Supervisor/Associate
Description of Work Unit
BioMARC is a contract manufacturing organization (CMO) of FDA regulated products. It was created to fill an industry need for higher containment biologic manufacturing. BioMARC is a nonprofit CMO owned and operated by CSU,and was created to translate and produce biopharmaceutical products for non-clinical, clinical, and commercial use under Biosafety level 2, 3 and Select Agent biosecurity conditions. In addition to manufacturing and testing services, BioMARC offers product and process development services, which includes the creation of development programs focused on implementing cGMP regulations and scalability issues.
This open application pool is a continuous, year-long advertisement for those candidates interested in applying to the Production Supervisors/Associates pool. Open positions may not be available at the specific time of your submission; however, once a position becomes available, candidates in the pool will be screened.
Under the supervision of Production Manager, the Production Supervisor/Associate will be responsible for production activities of a cGMP manufacturing campaign under FDA regulations. This position requires gaining escalating levels of experience in executing complicated batch production records for the creation and/or processing of production materials. Employees will work within an FDA recognized Quality System (or similar) using Quality Assurance approved batch cards, SOPs, protocols and/or the like. Continuous directed and self-directed training in the US Code of Federal Regulation fields of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and/or Quality Assurance/Control will be expected of each employee. Employees will physically perform complex laboratory techniques in rooms that require specialized manufacturing and biocontainment protective gowning and equipment. Entering a Biosafety level 3 laboratory is likely. Moreover, employees will think critically through instructions and make professional judgments with regard to compliance, quality and continuous improvement paradigms. Employees will investigate and report on incidents and provide intelligent corrective proposals. In addition to GMP work, Process Development, Pre-clinical Production and Non-Clinical production/research support may be assigned with the expectations that the employee make use of skills similar to that described above.
Required Job Qualifications
Research Associate I:
- 0-3 years of professional experience
- Bachelor’s degree in the science’s or related field
Research Associate II:
- +3 years of professional experience
- Bachelor’s degree in the science’s or related field
- Master’s degree in the sciences or related field
Research Associate III:
- +5 years professional experience
- Bachelor’s degree in the sciences
- +2 years professional experience
- Master’s degree in the sciences
- PhD in the sciences
Preferred Job Qualifications
- Preferred degree from one of the following areas: microbiology, biotechnology, cell biology, biochemistry, chemical/biomedical engineering, pharmacology, or related field.
- Experiences in a contract manufacturing or other regulated environment.
- Experience in US code of federal regulation fields of GMP, GLP, GXP
- Biosafety Level 3 experience/ or high containment facility
- Experience in microbiology or cell biology type laboratory.
- Reflecting departmental and institutional values, candidates are expected to have the ability to advance the Department’s commitment to diversity and inclusion.
Job Duty Category Production Duty/Responsibility
- Create/implement/execute written procedures for biological manufacturing processes, including purification steps and sample testing methods of production campaigns.
- Independently analyze complex manufacturing data sets, summarize findings, perform risk analysis, and chart corrective actions. Must consistently exercise discretion and judgment to meet production standards in GMP environment.
- Perform both simple and complex laboratory procedures such as cell culture, protein purifications, DNA/RNA manipulations, immunohistochemistry, etc.
Percentage Of Time 60
Job Duty Category Quality Duty/Responsibility
- Complete sophisticated documentation requirements for all GMP activities following Good Documentation Practices (GDP). Must be able to justify all written records to Regulatory Auditors (e.g., FDA) in person.
- Support in the creation of controlled documents such as specification sheets, production records, protocols, reports, SOPs and other directive documents.
- Support the clean room maintenance of the production and support rooms. This involves the physical cleaning of floors, walls, ceilings, equipment and other surface areas. Must analyze microbial flora results and respond to contaminant levels.
- Required to manage and record non-batch card laboratory activities daily in project-specific laboratory notebooks under GDP.
Percentage Of Time 25
Job Duty Category Administrative Duty/Responsibility
- Perform other duties as required.
- Facilities, Operations and Validation department support
- Clean Ops Unit Support
- General Operational Duties
- Takes responsibility for maintaining material inventories and equipment qualifications for manufacturing use. This includes making the right decisions for types of GMP grade materials and activities needed to generate GMP grade materials.
- Perform other duties as required.
Percentage Of Time 15
Special Instructions to Applicants
The job title categories within this pool are for positions (when available) that are within a range of 0.5-1.0 Full Time Equivalent (FTE) effort (i.e., 50-100% work effort); Not to drop below the U.S. Fair Standard Labor Act dollar value thresholds for exempt employees. Hiring into a particular position at a specific FTE effort is based on the availability of task-specific funds, one’s skill set and other variables. Please note that this FTE effort and your salary will be very clearly communicated to you prior to hiring. Continued employment is not guaranteed and is also based on the availability of task-specific funds, one’s skill set and other variables.
NOTE 1: Applications will be accepted on a continuous basis. Candidates are likely to be selected prior to the closing date.
NOTE 2: This open pool will expire on 02/01/19 and individuals will need to reapply to any new opening to be considered beyond that date.
References will not be contacted without prior notification of candidates.
Search Contact BioMARCJobs@colostate.edu
Special Instructions to Applicants
APPLICATION INSTRUCTIONS AND INFORMATION
- Clearly document job duties you have performed that relate to minimum qualifications, preferred qualifications, and essential job duties in the Work Experience section on the application. Human Resources must be able to evaluate your experience based on this information.
- Clearly outline dates of employment and hours worked per week for each employment experience listed in the Work Experience section of the Application so that Human Resources can calculate full-time work experience.
- The APPLICATION is the only document that will be utilized to determine if minimum qualifications, as outlined in the job posting, have been met. The Application is considered to be the legal document on file; resumes will not be reviewed for minimum qualification requirements.
- If an Application is considered “Incomplete”, the Application will be removed from consideration for the position.
- An Application is incomplete if no current/ previous employment is included in the Work Experience section of the Application.
- An Application is incomplete if “see resume” (or something similar) is noted, or previous employment does not contain job duties for every position in the Work Experience section of the Application.
- Positions requiring a degree or if using education as a substitution for work experience (e.g.: Associate or Bachelor’s) transcripts are required in order to verify receipt of the required degree or coursework. If official or unofficial transcripts are not supplied at the time of application, the Application is incomplete.
- When a resume is listed as a required document, it may be used in the comparative analysis/ evaluation process to determine the candidates that most closely meet the qualifications of the position. This process occurs after an application has passed the minimum qualifications screening.
- Resumes will not be accepted in place of a completed application; however, some positions may still require a resume as a component for complete application materials.
**Please see the Required Documents section of the posting.
- The selection process for State Classified positions may include an exam(s), which requires candidates to physically appear (at the CSU campus in Fort Collins, CO) at the candidates’ own expense.
- All status updates for this position will be sent via email from firstname.lastname@example.org. In addition to your Inbox, remember to check the Deleted and Junk folders for these important communications.
- Pertinent updates to your Application status can be obtained by logging into your application account at https://jobs.colostate.edu
- For any assistance completing the application, please contact Ashley Harvey at A.Harvey@colostate.edu or 970-491-3505.
DEPARTMENT CONTACT INFORMATION
- Please check the Help link online at https://jobs.colostate.edu/help/ for assistance on your application or for answers to Frequently Asked Questions.
- All other inquiries should be directed to the Colorado State University Human Resources Office (970) 491- MyHR(6947).
Colorado State University is committed to providing an environment that is free from discrimination and harassment based on race, age, creed, color, religion, national origin or ancestry, sex, gender, disability, veteran status, genetic information, sexual orientation, gender identity or expression, or pregnancy and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Colorado State University is an equal opportunity/equal access/affirmative action employer fully committed to achieving a diverse workforce and complies with all Federal and Colorado State laws, regulations, and executive orders regarding non-discrimination and affirmative action. The Office of Equal Opportunity is located in 101 Student Services.
The Title IX Coordinator is the Executive Director of the Office of Support and Safety Assessment, 123 Student Services Building, Fort Collins, CO 80523 -2026, (970) 491-7407.
The Section 504 and ADA Coordinator is the Associate Vice President for Human Capital, Office of Equal Opportunity, 101 Student Services Building, Fort Collins, CO 80523-0160, (970) 491-5836.
Background Check Policy Statement
Colorado State University (CSU) strives to provide a safe study, work, and living environment for its faculty, staff, volunteers and students. To support this environment and comply with applicable laws and regulations, CSU conducts background checks. The type of background check conducted varies by position and can include, but is not limited to, criminal (felony and misdemeanor) history, sex offender registry, motor vehicle history, financial history, and/or education verification. Background checks will be conducted when required by law or contract and when, in the discretion of the university, it is reasonable and prudent to do so.
Employment and Appeal Rights
If you receive notice that you have been eliminated from consideration for the position, you may protest the action by filing an appeal with the State Personnel Board/State Personnel Director within 10 days from the date you receive notice of the elimination. Also, if you wish to challenge the selection and comparative analysis process, you may file an appeal with the State Personnel Board/State Personnel Director within 10 days from the receipt of notice or knowledge of the action you are challenging.
Refer to Chapters 4 and 8 of the State Personnel Board Rules and Personnel Director’s Administrative Procedures, 4 CCR 801, for more information about the appeals process. The State Personnel Board Rules and Personnel Director’s Administrative Procedures are available at www.colorado.gov/spb.
A standard appeal form is available at: www.colorado.gov/spb. If you appeal, your appeal must be submitted in writing on the official appeal form, signed by you or your representative, and received at the following address within 10 days of your receipt of notice or knowledge of the action: Colorado State Personnel Board/State Personnel Director, Attn: Appeals Processing, 1525 Sherman Street, 4th Floor, Denver, CO 80203. Fax: 303-866-5038. Phone: 303-866-3300. The ten-day deadline and these appeal procedures also apply to all charges of discrimination.