Manufacturing Associate II

Wave Life Sciences

Wave Life Sciences

Lexington, MA, USA
Posted on Friday, April 26, 2024

Job Description

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a preclinical program in obesity. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

Description:

The Manufacturing Associate II performs mainly both small and largescale production of oligonucleotides. This person will also need to perform purification, desalting UF/DF, and lyophilization, under minimal supervision. Responsible for maintaining strict quality standards and adhering to cGMP practices throughout the process. This position is a lab based position located in our Lexington, MA facility.

Experience:

  • Requires Bachelor’s degree in biological science(s) or related engineering field and 3+ years GMP or 1+ years oligo experience, or Master’s degree with 1+ years GMP experience
  • Solution prep/ process monitoring experience, familiarity with Unicorn or equivalent software, and upstream and downstream experience
  • Ability to work interdepartmentally, train others, and write SOPs
  • Has a strong grasp of GMPs and some troubleshooting skills

Responsibilities:

  • Identify and implement SOP/MFG batch record improvement
  • Execute manufacturing operations using current technologies and automation
  • Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation
  • Practice safe work habits and adhere to safety procedures and guidelines
  • Monitor process operations to ensure compliance with specifications
  • Adhere to gowning procedures and maintain a clean general operating area
  • Adhere to documented waste handling procedures to respect environmental regulations
  • Utilize knowledge to improve operational efficiency
  • Review completed batch records and work with compliance specialists to write reports and deviations
  • Assist with process transfers and development manufacturing
  • Interfaces with manufacturing support groups to align on production requirements

Key Skills:

  • Displays a practical understanding of technical know how related to good manufacturing practices (GMPs), semi-automatic and manual equipment, basic lab skills and company policy and procedure, and applies knowledge to practical application
  • Has demonstrated a basic understanding of oligonucleotide synthesis and purification, actively seeks out opportunities for continued learning
  • Skillfully identifies issues and develops appropriate options, recommendations, and potential solutions to problems
  • Fully understands health and safety requirements and follows best practices
  • Identifies and appropriately reports safety or compliance issues
  • Shares knowledge and best practices
  • Maintains impeccable record keeping
  • Discusses proprietary information in a sensitive manner and is mindful of documentation security at all times
  • Regularly produces accurate work on time
  • Produces consistent work in a fast-paced environment with changing priorities
  • Actively plans ahead for routine and cyclical work and projects and communicates unanticipated changes to proactively improve efficiencies in a rapidly changing environment

Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences’ employees to perform their job duties may result in discipline up to and including discharge.

We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.