This position formulates and aliquots reagents in a controlled manufacturing environment. This position requires the ability to work in a controlled environment and follow specific procedures and documenting those results in a “good documentation practices manner.” This role will also require attention to detail and the ability to accurately print labels. Finally this person will be require to inspect materials and verify specific details related to those materials (lot number, expiration date, etc.) prior to using those materials or allowing those materials into inventory.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Follows cGMP and ISO standards or guidelines as they apply to manufacturing

• Supports Manager with formulation of solutions, from line clearance through dispensing/capping of vials, following standard operating procedures and guidelines; solutions include aqueous solutions containing salts, organics, acids, bases and/or modified DNA and organic solutions

• Reviews manufacturing batch records as directed for accuracy and adherence to good documentation practices prior to in-process items release

• Conducts and analyzes test results for compliance to specifications and reports abnormalities.

• Responsible for on-time completion of scheduled work orders

• Ensures the effective use of materials, equipment, and Formulations team members in producing quality products

• Supports departmental projects. Partners with QC, PTS, QA and/or R&D on OOS/NCR/CAPA investigations as needed

• Support Management with validation and stability studies, executes protocols, analyzes data, generates reports, investigates non-conformances for MRB

• Prepares operating procedures and work instructions to govern lab processes and for the introduction of new items into Formulations team production

• May lead special projects as needed and perform additional duties as required

POSITION REQUIREMENTS

Education and Experience

• A.A.S. or B.S. degree, preferred, in basic sciences or life sciences and/or 1+ years of experience in a formulation manufacturing environment

Skills – Technical

• Technical knowledge of scientific practices and prefer direct experience with pipetting and formulating solutions

• Knowledge of safety precautions required for working with biohazards and blood borne pathogens

• Good communication, technical writing, and diplomacy skills

• Organizational, planning and detail follow-up skills required

• Ability to work in a multi-functional team environment

• Ability to handle and resolve conflicts and work under schedule/milestone pressures

• Demonstrated ability to be flexible and resourceful

• Must be proficient in writing, and communicating in the English language

Skills – General

• Strong influencing and interpersonal skills and the ability to work well with others in a proactive, positive and constructive manner

• Strong quality-orientation with attention to detail and a desire to deliver service excellence is essential

• Must be a hands-on, self-directed, organized and a conscientious individual

• Complete work in a timely, accurate and thorough manner and is conscientious about assignments

• Must be able to think and work both tactically and strategically to provide operational needs to GenMark’s business

• Ability to read, write and analyze complex documents

• Ability to respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, peers and individuals

• Ability to work effectively, exhibit a professional manner and establish constructive working relationships

• Proficient with Microsoft Office applications

• Strong problem-solving, judgment and decision-making skills

WORK ENVIRONMENT

The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment.

While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.

*Relocation assistance is NOT available for this role*

The expected salary range for this position based on the primary location of California is $43,300.00 to $80,500.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.