cGMP Specialist I- Cyclotron at Houston Methodist in Houston, Texas

Job Description:

Work Shift: DAY

Work Week: M - F

1. Demonstrated knowledge and experience in multistep small molecule microscale synthesis;

2. Knowledge in basic analytical chemistry, including High Performance Liquid Chromatography (HPLC);

3. Experience or willingness to handle radioactivity isotopes, working in a radiochemistry Lab environment in compliance with State radiation safety guidance;

4. Capability to lift 50 pounds;

5. Experience or willingness to work in a highly regulated radiopharmaceutical drug manufacturing facility in compliance with FDA cGMP guidance.

PATIENT AGE GROUP(S) AND POPULATION(S) SERVED

Not applicable.

HOUSTON METHODIST EXPERIENCE EXPECTATIONS

o Provide personalized care and service by consistently demonstrating our I CARE values:

- INTEGRITY: We are honest and ethical in all we say and do.

- COMPASSION: We embrace the whole person including emotional, ethical, physical, and spiritual needs.

- ACCOUNTABILITY: We hold ourselves accountable for all our actions.

- RESPECT: We treat every individual as a person of worth, dignity, and value.

- EXCELLENCE: We strive to be the best at what we do and a model for others to emulate.

o Focuses on patient/customer safety

o Delivers personalized service using HM Service Standards

o Provides for exceptional patient/customer experiences by following our Standards of Practice of always using Positive Language (AIDET, Managing Up, Key Words)

o Intentionally rounds with patients/customers to ensure their needs are being met

o Involves patients (customers) in shift/handoff reports by enabling their participation in their plan of care as applicable to the given job

PRIMARY JOB RESPONSIBILITIES

PEOPLE - 15 %

1. Collaborates with cross functional teams including research, process development, quality assurance and quality control. (EF)

2. Works with research team members to assist them with transitioning their research processes to compliant cGMP SOPs. (EF)

3. Participates in multi-functional project teams, as necessary.

SERVICE - 20 %

1. Participates in internal audits and external inspections by Regulatory Agencies. (EF)

2. Responds to calls/alarms off hours and weekends for facility systems and equipment failures.

3. Demonstrates the components of the ICARE values statement.

QUALITY/SAFETY - 45 %

1. Ensures development, pre-clinical and clinical product supply is executed effectively against changing demand schedule and meets quality requirements. (EF)

2. Assists in internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and cGMP Core policies and procedures. (EF)

3. Follows all safety rules while on the job. Reports accidents promptly and corrects minor safety hazards.

4. Completes all hospital required and job-related in-services and applies the information as needed.

FINANCE - 5 %

1. Works in an efficient and cost-conscious manner.

GROWTH/INNOVATION - 15 %

1. Assists Quality Assurance Manager, cGMP Core Director and/or team members in defining release testing requirements, developing and executing protocols, performing periodic updates and/or revisions to SOPs. (EF)

2. Interfaces with core users to assist in the translation of research processes to the cGMP manufacturing facility.

This job description is not intended to be all inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.

EDUCATION REQUIREMENTS

o BA/BS with 3 years experience or Masters with 1 year experience

EXPERIENCE REQUIREMENTS

o 3 years experience in cGMP quality assurance or manufacturing with a BA/BS or 1 year experience in cGMP quality assurance or manufacturing with a Masters degree

CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED

o None

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

o Biotechnology, pharmaceutical industry experience with exposure cGMP manufacturing operations.

o Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations.

o Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security.

o Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles.

SUPPLEMENTAL REQUIREMENTS

Work Attire Yes/No

Uniform No

Scrubs No

Business professional Yes

Other (dept approved) No

On-Call* Yes, on a limited basis (for Exempt jobs only)

*Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Event, etc) regardless of selection above.

Travel**

May require travel within No

Houston Metropolitan area

May require travel outside No

of Houston Metropolitan area

**Travel specifications may vary by department.

Please note any other special considerations to this job: N/A

Houston Methodist is an Equal Opportunity Employer.

Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity,national origin, age, disability, status as a protected veteran or other characteristics protected by law.

VEVRAA Federal Contractor - priority referral Protected Veterans requested.

Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies and treatments. The research institute was created to provide the infrastructure and support for these endeavors, and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 277 principal investigators and has more than 840 ongoing clinical trials.