Manager, Production

5 months ago

Mississauga, Canada Candoo Pharmatech Company Inc Full time

**Responsibilities**:

- Accountable for the daily and weekly targets for the manufacturing/production team, including scheduling work shifts to meet the expected production metrics.
- Ensure staff are fully trained and adhere to all SOPs, GMP guidelines, Health Canada/FDA regulations and safety requirements.
- Supervising and maintaining a highly engaged, production team of equipment operators and technicians
- Provide after-hours support for escalations and resolving production issues.
- Works with appropriate stakeholders to resolve safety, quality and efficiency issues.
- Expedite receiving and delivery of Material and Pharmaceutical excipients into the facility.
- Work with the Quality Assurance to ensure that IQOQ is performed and up to date for the manufacturing equipment and environment.
- Draft and submit SOPs, Work instructons (WIs) and Training records to Quality Assurance for approval
- Interact internally with Candoo teams such as Quality Operations/Assurance, Facilities and Maintenance, Material Management and Procurement to ensure the facility is running smoothly.
- Review the Candoo manufacturing approach and provide process improvement recommendations and oversee process enhancements as needed.

**Qualifications And Requirements**:

- Degree in Chemistry, Engineering, Pharmaceutical Operations or a related discipline.
- Minimum one year leading a team in a CDMO manufacturing environment preferred.
- Minimum of 3 years progressive supervisory experience in a GMP regulated environment, preferably in pharmaceutical manufacturing and packaging
- Proficiency with Microsoft Office programs and exposure to SAP or other ERP based software.
- Must possess excellent leadership abilities and communication skills as well as process troubleshooting skills with the ability to manage a variety of functions simultaneously.
- Excellent organizational and leadership skills with a demonstrated ability to handle multiple priorities in a fast-paced team oriented environment.

**About Candoo**:
Candoo Pharmatech Company Inc. is a technology-driven, customer-centric biopharmaceutical company and CDMO specializing in advanced formulation solutions for small and large molecules. Candoo believes an innovative, efficient and affordable drug delivery platform is pivotal to substantially reduce the cost of new drug access. We provide experienced, agile and cost-effective contract research, development and manufacturing end-to-end integrated services (CRDMO) including pre-formulation, formulation, analytical, dissolution, manufacturing, regulatory submission, GastroPlus modeling and toxicology evaluation for global pharmaceutical and biotech industries. We have proven track record of success to develop first-to-file products, achieve target drug absorption profile, pass bioequivalence studies right-first-time, and get regulatory approval within one review cycle. Our expertise spans a broad spectrum of oral, topical and parenteral dosage forms in the fields of NDA, 505b(2) and generics (ANDA). We focus on development of difficult-to-formulate and high technical barrier products. In addition to successful development of many first-to-file (Paragraph IV) complex generics for bioequivalent formulations and 505 b(2) for product life cycle management, we effectively support pharma, biotech and medical research institutions all over the world accelerate molecules to medicines with model-informed developability assessment, best fit formulation, scalable manufacturing process and faster turnaround time.

**Benefits**:

- Company pension
- Dental care
- Employee assistance program
- Extended health care
- On-site parking
- Paid time off
- RRSP match
- Vision care

Flexible Language Requirement:

- French not required

Schedule:

- Monday to Friday

Supplemental pay types:

- Bonus pay

**Experience**:

- Pharmaceutical manufacturing: 5 years (preferred)
- GMP facility work: 3 years (preferred)

Work Location: In person

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