Biomanufacturing Associates I, II, or III - Fort Collins, United States - Colorado State University

Description

The Biomanufacturing Associate are responsible for the implementation and execution of policies and procedures for the cGMP manufacturing of biologics. Individuals will be working within an FDA compatible Quality System using Quality Assurance approved SOPs, protocols and/or similar controlled documents.

Candidates must be able to physically perform complex laboratory techniques including, but not limited to, mammalian and bacterial cell culture, viral propagation, column chromatography, product fill/finish in rooms that require specialized manufacturing and biocontainment protective gowning and equipment. Entry and work in a Biosafety Level 3 laboratory is expected. In addition, work related to process development in support of Non-Clinical production/research may be assigned with the expectations that the employee makes use of skills similar to those described above. Successful candidates must be able to perform as part of a team and think critically through instructions, problem solve, and make professional judgments with regard to regulatory compliance, quality and continuous improvement paradigms.

The different position level(s) require escalating levels of experience in the understanding and application of scientific concepts and experience in a Biopharmaceutical manufacturing environment. The Required Job Qualifications section is written to reflect this. Required Job Qualifications Required qualification, rank and salary determined by specific position to be filled for each level:

Minimum Qualifications:

Level I:

Bachelors degree in biology, chemistry, or related field.

OR Bachelors degree in an unrelated field plus 1 year of professional experience related to the specific assignment or 1 year of experience in a contract manufacturing organization.

Level II:

Bachelors degree in biology, chemistry, or related field and 2 or more years of relevant professional experience or a Masters degree with no experience.

OR Bachelors degree in an unrelated field plus 3 years of professional experience in a contract manufacturing organization.

Level III:

Bachelors degree in biology, chemistry, or related field and 4 or more years of relevant professional experience.

OR a Masters degree with 2 years experience

OR a Bachelors degree in an unrelated field plus 5 years of professional experience in a contract manufacturing organization.

The successful candidate must be legally eligible to work in the at time of application; the Infectious Disease Research Center will not provide visa sponsorship for these positions. Preferred Job Qualifications

Relevant experience commensurate with the specific position to be filled in a cell biology or microbiology type laboratory.

Relevant experience commensurate with the specific position to be filled in a contract manufacturing or other regulated environment.

Relevant experience commensurate with the specific position to be filled in US code of federal regulation fields of GMP, GLP, and/or GXP.

Relevant Biosafety Level 2 and/or 3 experience or working in high containment facility.

Diversity Statement Reflecting departmental and institutional values, candidates are expected to have the ability to advance the Departments commitment to diversity and inclusion. Essential Duties Application Details