Industry Career Opportunities

Alphora

Position Title: Manager of Laboratory Technical Operations (LTO)

ARA – Avanti Rx Analytics Inc. is a Canadian owned Controlled Substances Contract testing, Extraction and Purification organization. We have a great team of highly educated, experienced, passionate, and committed personnel.

We offer competitive salary, exceptional career development, state-of-the-art facilities, and “the satisfaction that comes from knowing that the services we provide and the products we produce will improve the quality of human lives.

Job Summary:

This position requires that the candidate be proficient and skilled in the art of all aspects of analytical research, development, and Quality Control as they relate to method development, validation, transfer, and release for pharmaceuticals and nutraceuticals.

The Manager of Laboratory Technical Operation shall be responsible for the managing of Lab Technical Operations (LTO) operations and execution of assigned projects, the training of LTO staff, and in the leadership role for the development of department staff.

The Manager of LTO is also responsible for capital project management, OOS Investigations and Change Control related to the laboratory operation.

The candidate must have a broad and far-reaching understanding of the chemical literature, and extensive experience on; standard and novel methods and techniques such as HPLC; GC; Mass spectrometry; ICP-MS, UV and Infrared spectrometry.

The candidate must have direct experience in managing timelines, budgets and performance, including conducting performance reviews, coaching and developing staff.

Essential Job Requirements:

  • Directs, plans, and provides leadership for the activities of QC and R&D laboratory personnel to ensure compliance with cGMP regulations, Health Canada OCS standards, ARA Standards, established safety standards, and other regulatory requirements.
  • Ensures that all testing (chemical, analytical, and microbiological) are conducted in a timely fashion and within approved established framework (SOPs, analytical methods, etc.) and that all generated data reflect the commitments to integrity and quality.
  • Develops Standard Operating Procedures and Method Validation Protocols. Prepares and maintains Certificates of Analysis documentation.
  • Reviews methods from Analytical Development for implementation in Quality Control.
  • Supports analysts working with HPLC, GC, GC-MS, ICP-MS and other lab instruments.
  • Executes methods for the chemical analysis of drug products and raw materials to establish assay, purity and identity of the materials
  • Manages the day to day laboratory operation activities and the lab staff and supports the workflow.
  • Generates functional and technically sound validation reports and ensure the timely testing and prompt evaluation of data generated through testing.
  • Recruits and trains laboratory analysts to carry out functions of the Laboratory Technical Operations department. Periodically reviews the performance of direct reports with regards to the achievement of goals, objectives and key performance indicators.
  • Monitors expenses routinely to ensure operations remain within forecasted budgets.
  • Brings to the attention of the ARA Senior Management, information relating to the impact of legislation or any potential critical issues.
  • Performs additional duties related to managing the department as required
  • Where applicable trains laboratory analysts on new; methods, laboratory instrumentation, and any new regulatory requirements
  • Ensures compliance of team members (direct reports) with Safety and Employment policies such as; Respect in the Workplace, Prevention of Violence, and/or Harassment.
  • Provides assistance and training to staff with technical support/troubleshooting of analytical methods and instrumentation
  • Contacts vendor / manufacturer for service contracts when required.
  • Evaluates and recommends revisions to calibration and analytical method procedures on an ongoing basis and coordinates special projects to improve department operations and regulatory requirements
  • Ensures departmental training records for the LTO are current.
  • Ensures Job Descriptions are reviewed, signed and sent to Human Resources, annually.
  • Effectively communicates any delays, issues and problems to appropriate managers/supervisors and where applicable to the client of ARA.
  • Ensures scheduled work for calibration and service of lab instrumentation are followed and completed in a timely fashion.
  • Oversees timely review of all analytical testing records and documentation.
  • Monitors expenses routinely to ensure operations remain within forecasted budgets.
  • Brings to the attention of the Director, Quality Operations and Site Management Committee, information relating to the impact of legislation or any potential critical issues
  • Oversees instrument performance certification and qualification, and where applicable arranges equipment replacement, service, and repair.
  • Assists with business development visiting potential clients
  • Maintain relationships with clients serviced by ARA-Avanti Rx Analytics
  • Manage the laboratory staff by recruiting, selecting, orienting, and training employees; planning, monitoring, and appraising job results.

Education, Experience, Knowledge and Skills:

  • Minimum B.Sc. in Chemistry, Biochemistry, or closely related discipline.
  • Minimum Ten (10) years of experience in Quality Control and/or R&D within the pharmaceutical or healthcare industry, with at least three (3) years in a management role. Broad experience with regulatory and ICH standards associated with analytical method validation and qualification and stability.
  • Strong knowledge and application of compendia (USP, Eur. Ph. BP), cGMP, and Canadian, US, and European regulatory guidelines.
  • Skilled in problem solving and resolving issues.
  • Detail-oriented with excellent analytical and communication skills.
  • Proven organization and time management skills, as demonstrated through previous experience
  • Expertise with the calibration and maintenance of laboratory equipment as well as regulatory requirements for good documentation practices and cGMP.
  • Computer literacy in Microsoft Office and Electronic Data Acquisition Systems, and laboratory software packages such as empower.
  • Proficiency in English is a Must.
  • Thoughtful leadership with significant management experience
  • Excellent verbal, written and interpersonal skills are required for this position due to the regular interaction between departments as well as with suppliers and contacts outside the company.

If you meet the above requirements, we’d love to hear how you could contribute to our team!

To apply, please send an e-mail to careers@avantirx.com referencing “Laboratory Technical Operations Manager Position” in subject line together with your resume and a covering letter.

The above position is only applicable to the Canadian permanent residence citizens with a minimum degree in science and five years of direct Canadian pharmaceutical experience. We thank all applicants for your interest, however, only those selected for an interview will be contacted.

Alphora

Position Title: Account Manager | Location: Mississauga, Canada

With the continued expansion of Alphora Research’s active pharmaceutical ingredient (API) development and manufacturing capabilities, we are seeking candidates for the position of Associate Account Manager.

The Company

Alphora Research Inc. is a contract research organization that provides process development and GMP scale-up manufacturing services for small molecule APIs to global pharmaceutical and biotechnology companies. Alphora was founded in 2003, is staffed by 100 employees, and has well equipped synthetic R&D labs, analytical services, GMP Kilo Labs, GMP Pilot Plant and supporting QC/QA functions. Please refer to our website at www.alphoraresearch.com for further information on our company.

Basic Function

Reporting to the Sr. Account Manager, the Account Manager role is an entry level position within the BD group with an integration process to achieve an understanding of Alphora’s offerings, systems, markets and clients, with increasing levels of exposure and interaction with potential and active clients. The role will support the business development team in the preparation of proposals and in the monitoring of won business.

Major Duties

  • Preparation of proposals for new projects under the supervision of the Sr. Account Manager and the BD manager
    • Includes the coordination of the efforts of the departments involved in the preparation of the proposal
  • New project administration and monitoring

    • To ensure that timelines are being meet, to monitor deliverables, support customer interactions and monitor scope change of project for one or more projects and/or clients
    • Monitor key project milestones in conjunction with the Project leads
    • Provide support to the technical team in terms of the preparation of project updates and meeting minutes, scheduling of meetings and visits and preparation reports and other documents as needed
    • Responding and initiating communications with the client as needed
    • Liaising with the Finance group regarding billing milestones

Education, Experience and Attributes

  • University degree in analytical or organic chemistry or related field
  • Five or more years’ experience in pharmaceutical field in either a business or scientific role with a focus on project management
  • Minimum of 1 years’ experience in the use of Microsoft project or similar management tools
  • Must have the capacity to quickly develop an understanding of the drug development process
  • Ability to communicate effectively both internally and externally in a professional manner
  • Solid organizational and time management skills
  • Excellent presentation, negotiation and interpersonal skills
  • Self-motivated, positive attitude, work ethic and a team player

Please forward your resume to hr.office@alphoraresearch.com

PharmaScience

Position Title: Regulatory Affairs Specialist | Location: Montreal, Canada

SOMMAIRE DU POSTE / JOB SUMMARY

The Regulatory Affairs CMC Specialist assumes responsibilities within the Scientific Affairs department to ensure the completeness of CMC documentation for all product dossiers and timely market approvals. He/She may also take part in the evaluation of new opportunities and other cross-functional projects. The ideal candidate is highly organized with a desire and ability for continuous learning, has good communication skills and can adapt to changing priorities.

RESPONSABILITÉS & TÂCHES / RESPONSABILITIES & DUTIES

  • Prepares the CMC portions of regulatory dossiers for various products (OTC and Rx drugs, biologics, natural health products and medical devices) in target countries (Canada, US and Europe)
  • Assumes responsibility for the timely submission and approval of Canadian generic applications (ANDS) and CTAs for bioequivalence trials
  • Assumes responsibility for the timely submission and approval of US generic applications (ANDA)
  • Assists when necessary in negotiations with regulatory agencies and in compilation of responses during clarifications requests
  • Participates in the analysis of CMC data during evaluation of new opportunities or due-diligences and provides input for decision making and risk mitigation for various dosage forms
  • Effectively liaises with corporate partners and participates in internal and external meetings as required
  • Participates in elaboration of regulatory strategy as required and provides regulatory advice to other divisions (e.g., Business Development, Operations, etc.)
  • Participates in preparation of the CMC portion for pre-submission meetings with Health Authorities
  • Ensures post-market regulatory compliance
  • Participate in Peer Review of submissions before filing.
  • Develops working relationship with regulatory agency contacts

CARACTÉRISTIQUES DU POSTE / JOB SPECIFICATIONS

NIVEAU DE SCOLAIRTE & PERFECTIONNEMENT / EDUCATION & TRAINING

  • B.Sc. in chemistry, pharmacology, life science discipline or equivalent
  • M.Sc. in drug development/regulatory affairs or healthcare related professional degree is an asset

EXPÉRIENCE / EXPERIENCE

  • 5 years in the regulatory field within the pharmaceutical industry with a focus on CMC documentation
  • Good knowledge of the US and Canadian regulations and ability to interpret policies and guidelines
  • Good understanding of ICH guidelines, CTD requirements, pharmacopeias and SUPAC environment
  • Solid scientific knowledge
  • Good project management skills
  • Good knowledge of drug development process is an asset

HABILETÉS, CONNAISSANCES & APTITUDES / SKILLS, KNOWLEDGE & ABILITIES :

  • The candidate must have good analytical skills with high-level attention to detail and commitment to accuracy and depth. She/he must demonstrate an ability to put together submissions in CTD format.
  • The candidate must demonstrate adaptability in situations involving changes as well as the capacity to take action without having all the information. 
  • She/he must be able to work simultaneously on multiple projects and under constrained timelines; ability to prioritize and follow standards and processes.
  •  The candidate must feel comfortable both working independently and interacting with various departments and people as needed.  She/he must demonstrate the ability to determine, initiate and complete tasks.   
  • The candidate must demonstrate good interpersonal skills that will allow him/her to effectively function in a fast-paced, people oriented, team environment.  
  • Demonstrated proficiency in using Microsoft suite (including Word, Excel and PowerPoint) and Adobe.
  • Excellent communication skills (written and oral) in English (essential) and in French (asset).

To apply, please reference “REGULATORY AFFAIRS SPECIALIST" in subject line and submit resume and cover letter to zmaalouf@pharmascience.com


Position Title: Laboratory Analysts | Location: Brampton, Ontario

ARA Avanti Rx Analytics is looking for qualified and experienced employees to join the successful team. We currently have the following full time position available for Brampton:

Reports To: Laboratory Supervisor
Location: Brampton, Ontario

Primary Responsibilities:

  • Working in a very fast paced environment by performing full analytical testing of assigned materials or products within standard times and under minimum guidance.
  • The position relies heavily on comprehensive wet chemistry techniques, Dissolution, HPLC, GC, and AA testing on raw materials, in-process and final products per established SOP's and pharmacopoeial product specifications
  • Documenting and reporting results in accordance with GMP and GLP
  • Conducting laboratory investigation as required
  • Providing technical support to other analysts
  • Performing trouble-shooting on complex issues with respect to laboratory analysis and laboratory instrumentation
  • Performing all work in accordance with all established regulatory, compliance and safety requirements
  • Training junior analysts as required
  • Maintaining professional relationship with Internal/External Customers

Skills & Qualification Required:

  • Permanent residency and/or Canadian citizenship
  • University Degree in Science – preferably in Chemistry
  • Minimum of 2 years Quality Control experience in the Pharmaceutical industry in particular contract testing
  • Knowledge of GMP, GLP, Compendia, analytical techniques and method validation
  • Superior organizational and interpersonal skills
  • Ability to manage multiple projects and tasks concurrently and effectively
  • Sound theoretical and technical knowledge of chromatographic sciences and spectroscopic technologies such as UV, IR, GC, HPLC, AA, TOC
  • Sound understanding of cGMP, ICH and FDA requirements
  • Excellent written and oral communication skills is a must
  • Computer proficiency with MS Office programs
  • Ability to meet deadlines and prioritize tasks with strong attention to detail

The above positions are only applicable to permanent residence and/or Canadian citizens with a minimum degree in science.

To apply, please reference “Laboratory Analyst” in subject line and submit resume and cover letter with salary expectation to careers@avantirx.com

We thank all applicants for their interest, however, only those selected for an interview will be contacted. No phone calls please.


Position Title: Senior Laboratory Analysts | Location: Brampton, Ontario

ARA Avanti Rx Analytics is looking for qualified and experienced employees to join the successful team. We currently have the following full time position available for Brampton:

Reports To: Laboratory Supervisor
Location: Brampton, Ontario

The successful candidate will be working in a very fast paced environment by performing full analytical testing of assigned materials or products within standard times and under minimal guidance/supervision. This position relies heavily on comprehensive wet chemistry techniques, Dissolution, HPLC, GC, AA testing on raw materials, in-process and final products per established SOP's and pharmacopoeial product specifications.

Duties shall include, but are not limited to, the following:

  • Document and report results in accordance with GMP and GLP
  • Conduct laboratory investigation as required
  • Provide technical support to other analysts
  • Perform trouble-shooting on complex issues with respect to laboratory analysis and laboratory instrumentation
  • Perform all work in accordance with all established regulatory, compliance and safety requirements
  • Train junior analysts as required
  • Maintain professional relationship with Internal/External Customers
  • Any ad-hoc tasks assigned by the ARA management

Qualification:

  • Permanent residency and/or Canadian citizenship
  • B.Sc. degree in Chemistry or related discipline is a must
  • Minimum of 5 years Quality Control experience in the Pharmaceutical/Nutraceutical discipline, ideally in contract testing
  • Knowledge of GMP, GLP, Compendia, analytical techniques and method validation
  • Superior organizational and interpersonal skills
  • Ability to manage multiple projects concurrently and effectively
  • With GC experience
  • Sound theoretical and technical knowledge of chromatographic sciences and spectroscopic technologies such as UV, IR, GC, HPLC, AA, TOC
  • Sound understanding of cGMP, ICH and FDA requirements
  • Excellent written and oral communication skills is a must
  • Computer proficiency with MS Office programs
  • Ability to meet deadlines and prioritize tasks with strong attention to detail

The above positions are only applicable to permanent residence and/or Canadian citizens with a minimum degree in science and five years of direct experience.

To apply, please reference “Senior Laboratory Analyst” in subject line and submit resume with cover letter to careers@avantirx.com

We thank all applicants for their interest, however, only those selected for an interview will be contacted. No phone calls please.


Position Title: Tablet/Encapsulation Group Leader | Location: Arnprior, Ontario

At Pillar5 Pharma, we know that quality products come from quality people, so we’re always on the lookout for great talent. 

We currently have an immediate opening for a Permanent - Full Time Tablet/Encapsulation Group Leader

Reporting to the Formulations Manager, The Tablet / Encapsulation Group Leader ensures the continuous, safe and efficient production in all Compression and Encapsulation processes.

RESPONSIBILITIES:

  • Oversee and schedule the work of the personnel responsible for the set-up and operation of the compression, encapsulation and ancillary equipment
  • Ensure the maintenance, control, storage and inspection of the tablet tooling according to the approved procedures
  • Working in conjunction with the Technical Services department, develop and optimize equipment settings and processes for new product introductions
  • Trouble shooting and repair of the compression, encapsulation and ancillary equipment
  • Utilize Lean methodologies to identify best practices and drive continuous process improvement within the plant
  • Identify and resolve GMP and safety issues within the department
  • Perform technical, on the job training, for new operators and set-up personnel for compression, encapsulating and ancillary equipment
  • Complete the manufacturing review of tab/cap batch records as well as review of blending and coating batch records in a backup capacity

QUALIFICATIONS AND REQUIREMENTS:

  • Minimum ten years of pharmaceutical manufacturing experience in the optimization, set-up, maintenance, troubleshooting and operation of compression and encapsulating equipment
  • Post high school technology diploma in Science or Engineering or high school diploma with additional industrial experience and demonstrated team management skills
  • Comprehensive knowledge of the GMP guidelines for the fabrication of solid dosage forms
  • Experience with SAP production modules and Tooling Inspection / Analysis software
  • Thorough understanding of the techniques and equipment used for compression and encapsulation
  • Strong background in Lean Manufacturing concepts including SMED, 5S and OEE
  • Knowledge of proper care, control and inspection of tablet tooling
  • Strong mechanical, analytical, mathematical and computer skills
  • Excellent time management, organizational, interpersonal, and communication skills

APPLICATION PROCESS:
Please send your resume by 4:00 p.m., Friday, May 15, 2015 to:
Pillar5 Pharma Inc.
Human Resources
365 Madawaska Blvd.
Arnprior, Ontario K7S 0C9
E-Mail: HR@pillar5pharma.com

We appreciate all interest, however, only applicants considered for an interview will be contacted.

Interested applicants please click on the "Apply Now" icon submit your resume to HR@pillar5pharma.com


Position Title: Lab Manager | Location: Markham, Ontario

Department: Quality Assurance
Reports to: Director, Quality Assurance

JOB FUNCTION

This position is responsible for ensuring that products meet Estee Lauder quality standards. It provides direction to drive manufacturing plant and/or suppliers towards higher quality products and processes within and above compliance to regulations such as Health Canada GMP and US FDA. This position has responsibility for colour analysts, chemists, raw material sampler and other laboratory support staff. This position supports the accountability for product quality (including Canadian regulatory compliance) manufactured by Estee Lauder Canada plants and including products shipped through the Canadian Distribution center and third party facilities in Canada. This position uses their expertise to make judgment calls that support the best interest of the company and the customer globally.

RESPONSIBILITIES

  1. Develop a professional organization of QA Lab team to support the Estee Lauder Quality standard and Estee Lauder Canada operational business.
  2. Provides the coaching, training, and development necessary to enhance the competencies, skills, knowledge and expertise of the individuals that report directly. 
  3. Direct activities in the areas of Quality Assurance laboratories at Estee Lauder location and 3rd party suppliers in Canada.
  4. Supports and interfaces with GSR, Planning, NLM, R&D and Products for all brands produced in Canada.
  5. Assure that laboratory processes and activities complies to GMP and GLP and as required by Canadian drug GMP Regulations and US FDA.  Approve the disposition of products in accordance with Canadian drug GMP Regulations and US FDA.
  6. Assure that the laboratory of Canadian 3rd party facilities comply with Estee Lauder Quality standards and Canadian drug GMP regulations.
  7. Supports active programs for Quality process improvement throughout Canadian manufacturing and distribution locations.
  8. Manages budgetary controls for the laboratory group.
  9. Ensures responsible QA laboratory team has clearly defined annual objectives and ensures performance is reviewed against those objectives.
  10. Ensures timelines are met and results reported for Canada QA that aligns with the business objectives.
  11. Maintain and improve Quality systems and process in QA laboratory that will support the following activities:
    • Investigation of rejects, root cause analysis and corrective actions.
    • All processes are capable and in control.
    • Working practices are in-line with global company practices and procedures.
    • All complaints are investigated, improvements implemented and response made in a timely manner.
    • New product launches process capability and prevention of quality issues.
    • Regulatory compliance (GLP and GMP)
    • Monthly reporting, technical documentation, and documented procedures.

SKILLS REQUIRED

Education: BS in Science, Chemistry, Engineering or equivalent
Experience: 5+ years experience in QA Management or a related field

  • Thorough knowledge of manufacturing, production and testing processes and utilization of quality metrics
  • Experience in cosmetics, pharmaceuticals, or food industry manufacturing desirable
  • Good understanding of regulatory requirements for the manufacture of cosmetic drug products (including a thorough knowledge of Health Canada and US FDA regulations)
  • Experienced in using laboratory systems, tracking, trending results and data for continuous improvement and SAP

Competencies: strong managerial, organizational, human-relations/interpersonal skills, excellent written and verbal communication skills, high level of computer literacy, training and coaching skills, excellent analytical skills, good understanding of statistical and problem solving techniques, multi-task capability

Interested applicants please click on the "Apply Now" icon submit your resume to jobs@estee.ca